Trial Outcomes & Findings for Medication Treatment for Opioid Use Disorder in Expectant Mothers (NCT NCT03918850)
NCT ID: NCT03918850
Last Updated: 2026-06-04
Results Overview
Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of illicit opioids and/or their metabolites. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
140 participants
Primary outcome timeframe
From screening (at 6-30 weeks estimated gestational age) to delivery, an average of 10-34 weeks
Results posted on
2026-06-04
Participant Flow
Participant milestones
| Measure |
BUP-XR
Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly.
The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
|
BUP-SL
Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase.
The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.
|
|---|---|---|
|
Overall Study
STARTED
|
69
|
71
|
|
Overall Study
COMPLETED
|
57
|
57
|
|
Overall Study
NOT COMPLETED
|
12
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Medication Treatment for Opioid Use Disorder in Expectant Mothers
Baseline characteristics by cohort
| Measure |
BUP-XR
n=69 Participants
Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly.
The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
|
BUP-SL
n=71 Participants
Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase.
The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.1 years
STANDARD_DEVIATION 4.6 • n=9 Participants
|
31.4 years
STANDARD_DEVIATION 4.7 • n=27 Participants
|
31.2 years
STANDARD_DEVIATION 4.6 • n=267 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=9 Participants
|
71 Participants
n=27 Participants
|
140 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
10 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
65 Participants
n=9 Participants
|
65 Participants
n=27 Participants
|
130 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
10 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=9 Participants
|
57 Participants
n=27 Participants
|
116 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Opioid Craving Scale
|
2.7 score on a scale
STANDARD_DEVIATION 2.5 • n=9 Participants
|
3.7 score on a scale
STANDARD_DEVIATION 3.0 • n=27 Participants
|
3.2 score on a scale
STANDARD_DEVIATION 2.8 • n=267 Participants
|
|
Short Opioid Withdrawal Scale
|
7.0 score on a scale
STANDARD_DEVIATION 7.0 • n=9 Participants
|
5.8 score on a scale
STANDARD_DEVIATION 6.6 • n=27 Participants
|
6.4 score on a scale
STANDARD_DEVIATION 6.8 • n=267 Participants
|
PRIMARY outcome
Timeframe: From screening (at 6-30 weeks estimated gestational age) to delivery, an average of 10-34 weeksWeekly urine samples are shipped to a central laboratory, where they are analyzed for presence of illicit opioids and/or their metabolites. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants.
Outcome measures
| Measure |
BUP-XR
n=1136 urine samples
Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly.
The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
|
BUP-SL
n=1220 urine samples
Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase.
The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.
|
|---|---|---|
|
Percentage of Illicit Opioid-negative Urine Samples During Pregnancy
|
82.5 % Illicit opioid-negative urine samples
Standard Error 4.2
|
72.6 % Illicit opioid-negative urine samples
Standard Error 4.2
|
SECONDARY outcome
Timeframe: Delivery through 12 months postpartumWeekly urine samples are shipped to a central laboratory, where they are analyzed for presence of illicit opioids and/or their metabolites.
Outcome measures
| Measure |
BUP-XR
n=3 urine samples
Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly.
The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
|
BUP-SL
n=3 urine samples
Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase.
The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.
|
|---|---|---|
|
Percentage of Illicit Opioid-negative Urine Samples Postpartum
|
60.2 % Illicit opioid-negative urine samples
Standard Error 4.2
|
59.5 % Illicit opioid-negative urine samples
Standard Error 4.1
|
SECONDARY outcome
Timeframe: From screening (at 6-30 weeks estimated gestational age) to delivery, an average of 10-34 weeksAdherence to treatment from screening to delivery, checked weekly. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants.
Outcome measures
| Measure |
BUP-XR
n=69 Participants
Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly.
The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
|
BUP-SL
n=71 Participants
Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase.
The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.
|
|---|---|---|
|
Percentage of Days With Study Medication Adherence During Pregnancy
|
84.4 percentage of expected days adherent
Standard Error 3.1
|
84.9 percentage of expected days adherent
Standard Error 3.0
|
SECONDARY outcome
Timeframe: Delivery through 12 months postpartumAdherence to treatment from delivery through 12 months postpartum, checked weekly.
Outcome measures
| Measure |
BUP-XR
n=67 Participants
Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly.
The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
|
BUP-SL
n=69 Participants
Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase.
The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.
|
|---|---|---|
|
Percentage of Days With Study Medication Adherence - Postpartum
|
69.3 percentage of expected days adherent
Standard Error 4.3
|
75.5 percentage of expected days adherent
Standard Error 4.2
|
SECONDARY outcome
Timeframe: From screening (at 6-30 weeks estimated gestational age) to delivery, an average of 10-34 weeksWeekly urine samples are shipped to a central laboratory, where they are analyzed for presence of alcohol, illicit drugs and/or their metabolites. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants.
Outcome measures
| Measure |
BUP-XR
n=1136 urine samples
Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly.
The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
|
BUP-SL
n=1220 urine samples
Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase.
The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.
|
|---|---|---|
|
Percentage of Drug and Alcohol-negative Urine Samples During Pregnancy
|
58.8 Percentage of negative urine samples
Standard Error 3.4
|
52.2 Percentage of negative urine samples
Standard Error 3.4
|
SECONDARY outcome
Timeframe: Delivery through 12 months postpartumWeekly urine samples are shipped to a central laboratory, where they are analyzed for presence of alcohol, illicit drugs and/or their metabolites, excluding cotinine.
Outcome measures
| Measure |
BUP-XR
n=3 urine samples
Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly.
The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
|
BUP-SL
n=3 urine samples
Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase.
The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.
|
|---|---|---|
|
Percentage of Drug and Alcohol-negative Urine Samples - Postpartum Phase
|
34.7 Percentage of negative urine samples
Standard Error 3.3
|
35.0 Percentage of negative urine samples
Standard Error 3.2
|
SECONDARY outcome
Timeframe: Assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until deliveryThe scale consists of 3 items, measuring craving, cue-induced craving, and likelihood of using, rated on a visual analogue scale from 0-10. The total is calculated by averaging the 3 item scores. Higher scores indicate greater levels of opioid craving. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants. The measure was assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery, average score reported.
Outcome measures
| Measure |
BUP-XR
n=67 Participants
Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly.
The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
|
BUP-SL
n=70 Participants
Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase.
The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.
|
|---|---|---|
|
Opioid Craving Scale - Pregnancy
|
1.9 score on a scale
Standard Error 0.2
|
2.5 score on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Assessed at months 1, 3, 6, 9, and 12 post-deliveryThe scale measures craving, cue-induced craving, and likelihood of using, rated on a visual analogue scale from 0-10. The total is calculated by averaging the 3 item scores. Higher scores indicate greater levels of opioid craving. The measure was assessed at months 1, 3, 6, 9, and 12 post-delivery, average score reported
Outcome measures
| Measure |
BUP-XR
n=66 Participants
Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly.
The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
|
BUP-SL
n=67 Participants
Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase.
The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.
|
|---|---|---|
|
Opioid Craving Scale - Postpartum
|
1.5 score on a scale
Standard Error 0.2
|
1.7 score on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: At deliveryThe information was derived from either medical records or the birth certificate. Information was not obtained for 74 participants.
Outcome measures
| Measure |
BUP-XR
n=30 Participants
Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly.
The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
|
BUP-SL
n=36 Participants
Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase.
The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.
|
|---|---|---|
|
Adequacy of Prenatal Care Utilization Index
Inadequate
|
36.7 percentage of participants
8.9
|
19.4 percentage of participants
6.7
|
|
Adequacy of Prenatal Care Utilization Index
Intermediate
|
13.3 percentage of participants
6.3
|
16.7 percentage of participants
6.3
|
|
Adequacy of Prenatal Care Utilization Index
Adequate
|
23.3 percentage of participants
7.9
|
13.9 percentage of participants
5.8
|
|
Adequacy of Prenatal Care Utilization Index
Adequate Plus
|
26.7 percentage of participants
8.2
|
50.0 percentage of participants
8.5
|
SECONDARY outcome
Timeframe: Assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until deliveryMeasure of maternal opioid withdrawal symptoms. The Short Opiate Withdrawal Scale-Gossop has scores rated on a scale of 0 (none) to 3 (severe) per question. The total score of the SOWS-Gossop ranges from 0-30. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants. The measure was assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery, average score reported.
Outcome measures
| Measure |
BUP-XR
n=67 Participants
Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly.
The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
|
BUP-SL
n=70 Participants
Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase.
The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.
|
|---|---|---|
|
Short Opiate Withdrawal Scale (SOWS)-Gossop - Pregnancy
|
5.6 score on a scale
Standard Error 0.5
|
6.2 score on a scale
Standard Error 0.5
|
SECONDARY outcome
Timeframe: Assessed at months 1, 3, 6, 9, and 12 post-deliveryMeasure of maternal opioid withdrawal symptoms. The Short Opiate Withdrawal Scale-Gossop has scores rated on a scale of 0 (none) to 3 (severe) per question. The total score of the SOWS-Gossop ranges from 0-30. The measure was assessed at months 1, 3, 6, 9, and 12 post-delivery, average score reported.
Outcome measures
| Measure |
BUP-XR
n=66 Participants
Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly.
The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
|
BUP-SL
n=67 Participants
Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase.
The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.
|
|---|---|---|
|
Short Opiate Withdrawal Scale (SOWS)-Gossop - Postpartum
|
4.1 score on a scale
Standard Error 0.5
|
5.3 score on a scale
Standard Error 0.5
|
SECONDARY outcome
Timeframe: Neonate discharge from hospital, typically within 1 month postpartumUse of opioid medication for NOWS symptoms will be abstracted from the medical record.
Outcome measures
| Measure |
BUP-XR
n=11 Participants
Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly.
The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
|
BUP-SL
n=13 Participants
Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase.
The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.
|
|---|---|---|
|
Opioid Medication for Neonatal Opioid Withdrawal Syndrome (NOWS) Symptoms
|
10.0 Total amount of morphine for NOWS-mg
Standard Error 3.2
|
10.4 Total amount of morphine for NOWS-mg
Standard Error 3.2
|
SECONDARY outcome
Timeframe: Neonate discharge from hospital, typically within 1 month postpartumNumber of days of NOWS treatment for those infants that did receive it, abstracted from the medical record.
Outcome measures
| Measure |
BUP-XR
n=19 Participants
Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly.
The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
|
BUP-SL
n=18 Participants
Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase.
The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.
|
|---|---|---|
|
Total Days of Neonatal Opioid Treatment During the Hospital Stay
|
10.9 Days of opioid treatment
Standard Error 2.2
|
14.8 Days of opioid treatment
Standard Error 3.0
|
SECONDARY outcome
Timeframe: Neonate discharge from hospital, typically within 1 month postpartumInfant hospital length of stay (LOS) defined as the infant's age, in days, at discharge will be abstracted from the medical record. (all infants)
Outcome measures
| Measure |
BUP-XR
n=65 Participants
Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly.
The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
|
BUP-SL
n=67 Participants
Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase.
The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.
|
|---|---|---|
|
Infant Hospital Length of Stay
|
8.5 Hospital length of stay, days
Standard Error 0.9
|
9.5 Hospital length of stay, days
Standard Error 1.0
|
SECONDARY outcome
Timeframe: Neonate discharge from hospital, typically within 1 month postpartumNOWS peak score will be abstracted from the medical record. The scale used is the Finnegan-modified; the score ranges from 0-46, a score of 8 or higher indicates withdrawal.
Outcome measures
| Measure |
BUP-XR
n=22 Participants
Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly.
The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
|
BUP-SL
n=23 Participants
Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase.
The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.
|
|---|---|---|
|
Neonatal Opioid Withdrawal Syndrome (NOWS) Peak Score
|
10.4 score on a scale
Standard Error 0.8
|
10.0 score on a scale
Standard Error 0.9
|
SECONDARY outcome
Timeframe: Neonate discharge from hospital, typically within 1 month postpartumFor example, whether the infant is discharged in custody of mother, other relative, foster/adoptive family, etc. This will be abstracted from the medical record. Maternal custody - number \& percentage.
Outcome measures
| Measure |
BUP-XR
n=66 Participants
Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly.
The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
|
BUP-SL
n=68 Participants
Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase.
The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.
|
|---|---|---|
|
Custody at Discharge
|
90.9 % of participants with maternal custody
3.5
|
89.7 % of participants with maternal custody
3.7
|
SECONDARY outcome
Timeframe: Neonate discharge from hospital, typically within 1 month postpartumWhether or not there is an open child protective services at discharge (yes/no) will be abstracted from the medical record. Percentage of cases open with child protective services.
Outcome measures
| Measure |
BUP-XR
n=64 Participants
Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly.
The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
|
BUP-SL
n=67 Participants
Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase.
The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.
|
|---|---|---|
|
Child Protective Services Open Case
|
32.8 % Case with child protective services
5.9
|
38.8 % Case with child protective services
6.0
|
SECONDARY outcome
Timeframe: 12 months postpartumTo screen for developmental issues in the infant. Developmental issues at 12 months - percentage. Developmental issues assessed with The Ages and Stages Questionnaire, third edition scores each item as Yes (10 points), Sometimes (5 points), or Not Yet (0 points), with total scores compared to cutoffs to identify delays.
Outcome measures
| Measure |
BUP-XR
n=52 Participants
Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly.
The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
|
BUP-SL
n=52 Participants
Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase.
The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.
|
|---|---|---|
|
Ages and Stages Questionnaire, Third Edition (ASQ-3)
|
17.3 % infants w/ dev. issues
5.2
|
15.4 % infants w/ dev. issues
5.0
|
Adverse Events
BUP-XR
Serious events: 9 serious events
Other events: 49 other events
Deaths: 0 deaths
BUP-SL
Serious events: 27 serious events
Other events: 59 other events
Deaths: 0 deaths
BUP-XR - Neonates
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
BUP-SL - Neonates
Serious events: 11 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
BUP-XR
n=69 participants at risk
Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly.
The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
|
BUP-SL
n=71 participants at risk
Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase.
The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.
|
BUP-XR - Neonates
n=67 participants at risk
Infants born to mothers in the BUP-XR arm of the study.
|
BUP-SL - Neonates
n=70 participants at risk
Infants born to mothers of the BUP-SL arm of the study.
|
|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Pre-Eclampsia
|
4.3%
3/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
4.2%
3/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational hypertension
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
5.6%
4/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal growth restriction
|
1.4%
1/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Pregnancy, puerperium and perinatal conditions
Placenta accreta
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum haemorrhage
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Pregnancy, puerperium and perinatal conditions
Premature labour
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Pregnancy, puerperium and perinatal conditions
Premature separation of placenta
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Pregnancy, puerperium and perinatal conditions
Uterine contractions during pregnancy
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Psychiatric disorders
Drug dependence
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Psychiatric disorders
Drug use disorder
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
2.8%
2/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Psychiatric disorders
Major depression
|
1.4%
1/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
1.4%
1/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Psychiatric disorders
Depression
|
1.4%
1/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
1.4%
1/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Psychiatric disorders
Substance-induced mood disorder
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
4.2%
3/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Psychiatric disorders
Violence-related symptom
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Infections and infestations
Pyelonephritis
|
2.9%
2/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Infections and infestations
Atypical pneumonia
|
1.4%
1/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Infections and infestations
COVID-19
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
1.4%
1/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Infections and infestations
Sepsis
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Surgical and medical procedures
Hospitalisation
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
2.8%
2/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Surgical and medical procedures
Drug titration
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Surgical and medical procedures
Umbilical hernia repair
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Gastrointestinal disorders
Gastritis
|
1.4%
1/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.4%
1/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
1/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Investigations
Blood pressure increased
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
1/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Nervous system disorders
Seizure
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Pregnancy, puerperium and perinatal conditions
Retroplacental haematoma
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Vascular disorders
Hypertension
|
1.4%
1/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
General disorders
Chest Pain
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Infections and infestations
COVID-19 Pneumonia
|
1.4%
1/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Injury, poisoning and procedural complications
Overdose
|
4.3%
3/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
General disorders
Drug withdrawal syndrome, neonatal
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
General disorders
Death, neonatal
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Congenital, familial and genetic disorders
Congenital absence of bile ducts
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Congenital, familial and genetic disorders
Spina bifida
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Renal and urinary disorders
Pyelocaliectasis
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Congenital, familial and genetic disorders
Hypospadias
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Pregnancy, puerperium and perinatal conditions
Weight decrease, neonatal
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
General disorders
Hypothermia
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.4%
1/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Congenital, familial and genetic disorders
Pyloric Stenosis
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.5%
1/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Congenital, familial and genetic disorders
Laryngomalacia
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.5%
1/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Congenital, familial and genetic disorders
VACTERL syndrome
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.5%
1/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.5%
1/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.5%
1/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia, neonatal
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.5%
1/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Metabolism and nutrition disorders
Weight gain poor
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
3.0%
2/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Investigations
Echocardiogram abnormal
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
1.5%
1/67 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
0.00%
0/70 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
Other adverse events
| Measure |
BUP-XR
n=69 participants at risk
Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly.
The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Injection: Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
|
BUP-SL
n=71 participants at risk
Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase.
The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Buprenorphine Sublingual Product: Sublingual buprenorphine (BUP-SL), administered daily.
|
BUP-XR - Neonates
n=67 participants at risk
Infants born to mothers in the BUP-XR arm of the study.
|
BUP-SL - Neonates
n=70 participants at risk
Infants born to mothers of the BUP-SL arm of the study.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
1/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
5.6%
4/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
2/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
8.5%
6/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Gastrointestinal disorders
Constipation
|
8.7%
6/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
9.9%
7/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
2/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
5.6%
4/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Gastrointestinal disorders
Nausea
|
14.5%
10/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
7.0%
5/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Gastrointestinal disorders
Vomiting
|
17.4%
12/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
9.9%
7/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
General disorders
Peripheral swelling
|
7.2%
5/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
2.8%
2/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Infections and infestations
COVID-19
|
13.0%
9/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
21.1%
15/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Infections and infestations
Gastroenteritis
|
8.7%
6/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
4.2%
3/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Infections and infestations
Tooth abscess
|
1.4%
1/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
8.5%
6/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Infections and infestations
Tooth infection
|
1.4%
1/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
7.0%
5/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
14.5%
10/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
15.5%
11/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Infections and infestations
Urinary Tract Infection
|
5.8%
4/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
12.7%
9/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
8.5%
6/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Nervous system disorders
Headache
|
8.7%
6/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
11.3%
8/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal growth restriction
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
5.6%
4/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
5.6%
4/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
2.9%
2/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
5.6%
4/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
1/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
7.0%
5/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Vascular disorders
Hypertension
|
5.8%
4/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
4.2%
3/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
|
Infections and infestations
Bacterial Vaginosis
|
0.00%
0/69 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
7.0%
5/71 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
—
0/0 • Consent through 1 year postpartum, up to 1 year and 8 months
Serious adverse events were assessed in the infants of participants who were still active in the trial at the point of delivery, which was 67 in the BUP-XR group and 70 in the BUP-SL group. Serious adverse events in the infants were assessed weekly by study staff.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee There is currently an embargo on releasing the results until they are published by JAMA Internal Medicine. The current estimated date of publication is March 16, 2026.
- Publication restrictions are in place
Restriction type: OTHER