Trial Outcomes & Findings for Assessing Maternal Post-partum Pain With Suppositories (NCT NCT01271855)
NCT ID: NCT01271855
Last Updated: 2018-03-07
Results Overview
The primary outcome is pain measured at 24-hours after delivery. Patients will be asked to report a Visual Analog Scale (VAS) pain score at 24-hours after delivery. This scale ranges from 0 to 10 (0=no pain and 10=worst pain).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
Twenty-four hours
Results posted on
2018-03-07
Participant Flow
For this study, participants were recruited between August 1, 2009 and October 1, 2011 (26 months)
Participant milestones
| Measure |
Glycerin Suppository
Women assigned to this arm receive a vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery.
|
Belladonna and Opioid Suppository
Women assigned to this arm receive a Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
52
|
|
Overall Study
COMPLETED
|
48
|
52
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The parity count for one participant in the Belladonna and opioid suppository group is unknown
Baseline characteristics by cohort
| Measure |
Glycerin Suppository
n=48 Participants
Women assigned to this arm receive a vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery.
|
Belladonna and Opioid Suppository
n=52 Participants
Women assigned to this arm receive a Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.40 years
STANDARD_DEVIATION 5.78 • n=48 Participants
|
29.29 years
STANDARD_DEVIATION 5.76 • n=52 Participants
|
29.34 years
STANDARD_DEVIATION 5.74 • n=100 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=48 Participants
|
52 Participants
n=52 Participants
|
100 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=48 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=48 Participants
|
19 Participants
n=52 Participants
|
36 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=48 Participants
|
22 Participants
n=52 Participants
|
46 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=48 Participants
|
11 Participants
n=52 Participants
|
18 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=48 Participants
|
1 Participants
n=52 Participants
|
1 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=48 Participants
|
6 Participants
n=52 Participants
|
13 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
White
|
24 Participants
n=48 Participants
|
25 Participants
n=52 Participants
|
49 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Other Race
|
2 Participants
n=48 Participants
|
7 Participants
n=52 Participants
|
9 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
15 Participants
n=48 Participants
|
13 Participants
n=52 Participants
|
28 Participants
n=100 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=48 Participants
|
52 participants
n=52 Participants
|
100 participants
n=100 Participants
|
|
Gravidity
|
2.5 Count of pregnancies
n=48 Participants
|
2 Count of pregnancies
n=52 Participants
|
2 Count of pregnancies
n=100 Participants
|
|
Parity
|
1 Pregnancies to a viable gestational age
n=48 Participants • The parity count for one participant in the Belladonna and opioid suppository group is unknown
|
1 Pregnancies to a viable gestational age
n=51 Participants • The parity count for one participant in the Belladonna and opioid suppository group is unknown
|
1 Pregnancies to a viable gestational age
n=99 Participants • The parity count for one participant in the Belladonna and opioid suppository group is unknown
|
|
Gestational Age
|
38.68 Weeks
STANDARD_DEVIATION 1.24 • n=47 Participants • The gestational age for one participant in the Belladonna and opioid suppository group is unknown, and the gestational age for one participant in the Glycerin suppository group is unknown
|
39.09 Weeks
STANDARD_DEVIATION 1.05 • n=51 Participants • The gestational age for one participant in the Belladonna and opioid suppository group is unknown, and the gestational age for one participant in the Glycerin suppository group is unknown
|
38.89 Weeks
STANDARD_DEVIATION 1.16 • n=98 Participants • The gestational age for one participant in the Belladonna and opioid suppository group is unknown, and the gestational age for one participant in the Glycerin suppository group is unknown
|
|
Route of Delivery
Normal spontaneous vaginal delivery (NSVD)
|
31 Participants
n=48 Participants
|
42 Participants
n=52 Participants
|
73 Participants
n=100 Participants
|
|
Route of Delivery
Cesarean
|
17 Participants
n=48 Participants
|
10 Participants
n=52 Participants
|
27 Participants
n=100 Participants
|
|
Breastfeeding
Breastfeeding
|
37 Participants
n=48 Participants
|
41 Participants
n=52 Participants
|
78 Participants
n=100 Participants
|
|
Breastfeeding
Not Breastfeeding
|
8 Participants
n=48 Participants
|
9 Participants
n=52 Participants
|
17 Participants
n=100 Participants
|
|
Breastfeeding
Breastfeeding is unknown or not reported
|
3 Participants
n=48 Participants
|
2 Participants
n=52 Participants
|
5 Participants
n=100 Participants
|
|
Visual Analogue Scale Pain Score
|
0 units on a scale
n=47 Participants • The baseline visual analogue pain score for two participants in the Belladonna and opioid suppository group is unknown, and the baseline visual analogue pain score for one participant in the Glycerin suppository group is unknown
|
0 units on a scale
n=50 Participants • The baseline visual analogue pain score for two participants in the Belladonna and opioid suppository group is unknown, and the baseline visual analogue pain score for one participant in the Glycerin suppository group is unknown
|
0 units on a scale
n=97 Participants • The baseline visual analogue pain score for two participants in the Belladonna and opioid suppository group is unknown, and the baseline visual analogue pain score for one participant in the Glycerin suppository group is unknown
|
PRIMARY outcome
Timeframe: Twenty-four hoursPopulation: The 24-hour visual analogue pain score for two participants in the Belladonna and opioid suppository group is unknown, and the 24-hour visual analogue pain score for one participant in the Glycerin suppository group is unknown
The primary outcome is pain measured at 24-hours after delivery. Patients will be asked to report a Visual Analog Scale (VAS) pain score at 24-hours after delivery. This scale ranges from 0 to 10 (0=no pain and 10=worst pain).
Outcome measures
| Measure |
Glycerin Suppository
n=47 Participants
Women assigned to this arm receive a vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery.
|
Belladonna and Opioid Suppository
n=50 Participants
Women assigned to this arm receive a Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery
|
|---|---|---|
|
Pain Level Twenty Four Hours After Delivery
|
1 units on a scale
Interval 0.0 to 3.0
|
2 units on a scale
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: Twenty-four hoursTwenty-four hours after delivery, the number of participants taking additional pain medications will be recorded.
Outcome measures
| Measure |
Glycerin Suppository
n=48 Participants
Women assigned to this arm receive a vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery.
|
Belladonna and Opioid Suppository
n=52 Participants
Women assigned to this arm receive a Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery
|
|---|---|---|
|
Number of Patients Taking Additional Pain Medications
Taking additional pain medications
|
40 Participants
|
47 Participants
|
|
Number of Patients Taking Additional Pain Medications
Not taking additional pain medications
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: DischargePopulation: The pain satisfaction at discharge score is unknown for eight participants in the Belladonna and opioid suppository group, and the pain satisfaction at discharge score is unknown for six participants in the Glycerin suppository group.
Patients' satisfaction with their pain control is recorded at the time of discharge using a five point scale ranging from 1 (Not Satisfied) to 3 (Okay) to 5 (Very Satisfied).
Outcome measures
| Measure |
Glycerin Suppository
n=42 Participants
Women assigned to this arm receive a vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery.
|
Belladonna and Opioid Suppository
n=44 Participants
Women assigned to this arm receive a Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery
|
|---|---|---|
|
Patient Satisfaction
|
4 units on a scale
Interval 3.0 to 5.0
|
5 units on a scale
Interval 3.0 to 5.0
|
Adverse Events
Glycerin Suppository
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Belladonna and Opioid Suppository
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Glycerin Suppository
n=48 participants at risk
Women assigned to this arm receive a vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery.
|
Belladonna and Opioid Suppository
n=52 participants at risk
Women assigned to this arm receive a Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery
|
|---|---|---|
|
Gastrointestinal disorders
Dry Mouth
|
25.0%
12/48 • Number of events 12 • Adverse event data were collected for 28 months
|
36.5%
19/52 • Number of events 19 • Adverse event data were collected for 28 months
|
|
Renal and urinary disorders
Difficulty Urinating
|
4.2%
2/48 • Number of events 2 • Adverse event data were collected for 28 months
|
5.8%
3/52 • Number of events 3 • Adverse event data were collected for 28 months
|
|
Eye disorders
Sensitivity to Light
|
0.00%
0/48 • Adverse event data were collected for 28 months
|
1.9%
1/52 • Number of events 1 • Adverse event data were collected for 28 months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/48 • Adverse event data were collected for 28 months
|
3.8%
2/52 • Number of events 2 • Adverse event data were collected for 28 months
|
|
General disorders
Dizziness
|
12.5%
6/48 • Number of events 6 • Adverse event data were collected for 28 months
|
5.8%
3/52 • Number of events 3 • Adverse event data were collected for 28 months
|
|
Eye disorders
Blurred Vision
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected for 28 months
|
1.9%
1/52 • Number of events 1 • Adverse event data were collected for 28 months
|
|
Gastrointestinal disorders
Constipation
|
6.2%
3/48 • Number of events 3 • Adverse event data were collected for 28 months
|
5.8%
3/52 • Number of events 3 • Adverse event data were collected for 28 months
|
|
General disorders
Nausea
|
10.4%
5/48 • Number of events 5 • Adverse event data were collected for 28 months
|
15.4%
8/52 • Number of events 8 • Adverse event data were collected for 28 months
|
|
General disorders
Emesis
|
4.2%
2/48 • Number of events 2 • Adverse event data were collected for 28 months
|
3.8%
2/52 • Number of events 2 • Adverse event data were collected for 28 months
|
|
Skin and subcutaneous tissue disorders
Itching
|
12.5%
6/48 • Number of events 6 • Adverse event data were collected for 28 months
|
7.7%
4/52 • Number of events 4 • Adverse event data were collected for 28 months
|
|
General disorders
Headache
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected for 28 months
|
3.8%
2/52 • Number of events 2 • Adverse event data were collected for 28 months
|
|
Ear and labyrinth disorders
Tinnitus
|
2.1%
1/48 • Number of events 1 • Adverse event data were collected for 28 months
|
0.00%
0/52 • Adverse event data were collected for 28 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place