Trial Outcomes & Findings for Maternal Buprenorphine-naloxone Treatment and the Infant (NCT NCT03291847)

NCT ID: NCT03291847

Last Updated: 2024-02-26

Results Overview

Fetal heart rate in beats per minute, mean over 60 minutes gestation. Fetal heart rate in msec at 24 weeks of gestation at times of peak maternal plasma drug concentrations

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

42 participants

Primary outcome timeframe

24 weeks of gestation

Results posted on

2024-02-26

Participant Flow

Participant milestones

Participant milestones
Measure	Buprenorphine-naloxone Treated Participants receiving buprenorphine-naloxone treatment for opioid use disorder during pregnancy fetal monitoring: Maternal fetal monitoring Buprenorphine Naloxone: Treatment for opioid use disorder
Overall Study STARTED	42
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Maternal Buprenorphine-naloxone Treatment and the Infant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Buprenorphine-naloxone Treated n=26 Participants Participants receiving buprenorphine-naloxone treatment for opioid use disorder during pregnancy fetal monitoring: Maternal fetal monitoring Buprenorphine Naloxone: Treatment for opioid use disorder
Age, Continuous	29.6 years STANDARD_DEVIATION 4.7 • n=39 Participants
Sex: Female, Male Female	26 Participants n=39 Participants
Sex: Female, Male Male	0 Participants n=39 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=39 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=39 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants
Race (NIH/OMB) Black or African American	9 Participants n=39 Participants
Race (NIH/OMB) White	17 Participants n=39 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants
Region of Enrollment United States	26 Participants n=39 Participants

PRIMARY outcome

Timeframe: 24 weeks of gestation

Population: Fetal monitoring performed for all participants enrolled in the study at that gestational age who met criteria for monitoring

Fetal heart rate in beats per minute, mean over 60 minutes gestation. Fetal heart rate in msec at 24 weeks of gestation at times of peak maternal plasma drug concentrations

Outcome measures

Outcome measures
Measure	Buprenorphine-naloxone Treated n=13 Fetuses Participants receiving buprenorphine-naloxone treatment for opioid use disorder during pregnancy fetal monitoring: Maternal fetal monitoring Buprenorphine Naloxone: Treatment for opioid use disorder
Fetal Heart Rate at 24 Weeks	143.64 beats per minute Standard Deviation 4.38

PRIMARY outcome

Timeframe: 28 weeks of gestation

Population: Fetal monitoring performed for all participants enrolled in the study at that gestational age who met criteria for monitoring

Fetal heart rate in beats per minute, mean over 60 minutes gestation. Fetal heart rate at 28 weeks of gestation at times of tpeak maternal plasma drug concentrations.

Outcome measures

Outcome measures
Measure	Buprenorphine-naloxone Treated n=16 Fetuses Participants receiving buprenorphine-naloxone treatment for opioid use disorder during pregnancy fetal monitoring: Maternal fetal monitoring Buprenorphine Naloxone: Treatment for opioid use disorder
Fetal Heart Rate at 28 Weeks Gestation	139.14 beats per minute Standard Deviation 3.93

PRIMARY outcome

Timeframe: 32 weeks of gestation

Population: Fetal monitoring performed for all participants enrolled in the study at that gestational age who met criteria for monitoring

Fetal heart rate in beats per minute, mean over 60 minutes. Fetal heart rate at 32 weeks of gestation at times of peak maternal plasma drug concentrations

Outcome measures

Outcome measures
Measure	Buprenorphine-naloxone Treated n=19 Fetuses Participants receiving buprenorphine-naloxone treatment for opioid use disorder during pregnancy fetal monitoring: Maternal fetal monitoring Buprenorphine Naloxone: Treatment for opioid use disorder
Fetal Heart Rate at 32 Weeks Gestation	135.82 beats per minute Standard Deviation 146.83

PRIMARY outcome

Timeframe: 36 weeks of gestation

Population: Fetal monitoring performed for all participants enrolled in the study at that gestational age who met criteria for monitoring

Fetal heart rate in beats per minute, mean over 60 minutes. Fetal heart rate at 36 weeks of gestation at times of peak maternal plasma drug concentrations.

Outcome measures

Outcome measures
Measure	Buprenorphine-naloxone Treated n=15 Fetuses Participants receiving buprenorphine-naloxone treatment for opioid use disorder during pregnancy fetal monitoring: Maternal fetal monitoring Buprenorphine Naloxone: Treatment for opioid use disorder
Fetal Heart Rate at 36 Weeks Gestation	131.99 beats per minute Standard Deviation 5.52

PRIMARY outcome

Timeframe: 24 weeks of gestation

Population: Fetal monitoring performed for all participants enrolled in the study at that gestational age who met criteria for monitoring

Total fetal movement at 24 weeks of gestation. Total number of fetal moves over 60 minutes via fetal monitoring at time of peak maternal plasma drug concentrations at 24 weeks of gestation.

Outcome measures

Outcome measures
Measure	Buprenorphine-naloxone Treated n=11 Fetuses Participants receiving buprenorphine-naloxone treatment for opioid use disorder during pregnancy fetal monitoring: Maternal fetal monitoring Buprenorphine Naloxone: Treatment for opioid use disorder
Total Fetal Movement at 24 Weeks Gestation	71.91 fetal movements Standard Deviation 13.8

PRIMARY outcome

Timeframe: 36 weeks of gestation

Population: Fetal monitoring performed for all participants enrolled in the study at that gestational age who met criteria for monitoring

Total fetal movement over 60 minutes via fetal monitoring at 36 weeks of gestation. Nimber of fetal movements over 60 minutes via fetal monitoring at times of peak maternal plasma drug concentrations at 36 weeks of gestation.

Outcome measures

Outcome measures
Measure	Buprenorphine-naloxone Treated n=15 Fetuses Participants receiving buprenorphine-naloxone treatment for opioid use disorder during pregnancy fetal monitoring: Maternal fetal monitoring Buprenorphine Naloxone: Treatment for opioid use disorder
Total Fetal Movement at 36 Weeks Gestation	59.07 fetal movements Standard Deviation 17.17

PRIMARY outcome

Timeframe: 28 weeks of gestation

Population: Fetal monitoring performed for all participants enrolled in the study at that gestational age who met criteria for monitoring

Total fetal movement over 60 minutes via fetal monitoring. Total fetal movement over 60 minutes via fetal monitoring at times of trough and peak maternal plasma drug concentrations at 28 weeks of gestation.

Outcome measures

Outcome measures
Measure	Buprenorphine-naloxone Treated n=15 Fetuses Participants receiving buprenorphine-naloxone treatment for opioid use disorder during pregnancy fetal monitoring: Maternal fetal monitoring Buprenorphine Naloxone: Treatment for opioid use disorder
Total Fetal Movement at 28 Weeks Gestation	70.06 fetal movements Standard Deviation 12.13

PRIMARY outcome

Timeframe: 32 weeks of gestation

Population: Fetal monitoring performed for all participants enrolled in the study at that gestational age who met criteria for monitoring

Total fetal movement over 60 minutes via fetal monitoring at 32 weeks of gestation. Number of fetal moves over 60 minutes via fetal monitoring at times of peak maternal plasma drug concentrations at 32 weeks of gestation.

Outcome measures

Outcome measures
Measure	Buprenorphine-naloxone Treated n=18 Fetuses Participants receiving buprenorphine-naloxone treatment for opioid use disorder during pregnancy fetal monitoring: Maternal fetal monitoring Buprenorphine Naloxone: Treatment for opioid use disorder
Total Fetal Movement at 32 Weeks Gestation	66.00 fetal movements Standard Deviation 19.13

Adverse Events

Buprenorphine-naloxone Treated

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Buprenorphine-naloxone Treated n=26 participants at risk Participants receiving buprenorphine-naloxone treatment for opioid use disorder during pregnancy fetal monitoring: Maternal fetal monitoring Buprenorphine Naloxone: Treatment for opioid use disorder
Musculoskeletal and connective tissue disorders pectus carinatum, mild	3.8% 1/26 • Number of events 1 • From the time of protocol enrollment up to 30 days of infant age, an average of 6 months Any adverse pregnancy or neonatal complication was reported. All pregnancies were tracked via the project obstetrician from the time of study enrollment until delivery. All infants were tracked from the time of delivery through 30 days of age. There were 26 pregnancies during the study. Two women had two pregnancies each.
Pregnancy, puerperium and perinatal conditions missed spontaneous abortion	3.8% 1/26 • Number of events 1 • From the time of protocol enrollment up to 30 days of infant age, an average of 6 months Any adverse pregnancy or neonatal complication was reported. All pregnancies were tracked via the project obstetrician from the time of study enrollment until delivery. All infants were tracked from the time of delivery through 30 days of age. There were 26 pregnancies during the study. Two women had two pregnancies each.
Gastrointestinal disorders congenital malformation	3.8% 1/26 • Number of events 1 • From the time of protocol enrollment up to 30 days of infant age, an average of 6 months Any adverse pregnancy or neonatal complication was reported. All pregnancies were tracked via the project obstetrician from the time of study enrollment until delivery. All infants were tracked from the time of delivery through 30 days of age. There were 26 pregnancies during the study. Two women had two pregnancies each.

Other adverse events

Adverse event data not reported

Additional Information

Lauren Jansson

Johns Hopkins University School of Medicine

Phone: 4105504114

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place