Trial Outcomes & Findings for Effect of Adjunctive Misoprostol Treatment on Blood Loss at Vaginal Delivery (NCT NCT02411916)
NCT ID: NCT02411916
Last Updated: 2021-09-30
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
143 participants
Primary outcome timeframe
1 day after delivery
Results posted on
2021-09-30
Participant Flow
Patient declined to participate in study
Participant milestones
| Measure |
Intervention Cases
patient receiving misoprostol
misoprostol: rectal insertion
|
Controls
patients not receiving misoprostol
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
70
|
|
Overall Study
COMPLETED
|
73
|
70
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention Cases
n=73 Participants
patient receiving misoprostol (rectal insertion)
|
Controls
n=70 Participants
patients not receiving misoprostol
|
Total
n=143 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=73 Participants
|
0 Participants
n=70 Participants
|
0 Participants
n=143 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
73 Participants
n=73 Participants
|
70 Participants
n=70 Participants
|
143 Participants
n=143 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=73 Participants
|
0 Participants
n=70 Participants
|
0 Participants
n=143 Participants
|
|
Age, Continuous
|
24 years
STANDARD_DEVIATION 6 • n=73 Participants
|
25 years
STANDARD_DEVIATION 6 • n=70 Participants
|
24.5 years
STANDARD_DEVIATION 6 • n=143 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=73 Participants
|
70 Participants
n=70 Participants
|
143 Participants
n=143 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=73 Participants
|
0 Participants
n=70 Participants
|
0 Participants
n=143 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
73 participants
n=73 Participants
|
70 participants
n=70 Participants
|
143 participants
n=143 Participants
|
|
consented and randomized pregnant patients
|
73 Participants
n=73 Participants
|
70 Participants
n=70 Participants
|
143 Participants
n=143 Participants
|
PRIMARY outcome
Timeframe: 1 day after deliveryOutcome measures
| Measure |
Intervention Cases
n=73 Participants
patient receiving misoprostol
misoprostol: rectal insertion
|
Controls
n=70 Participants
patients not receiving misoprostol
|
|---|---|---|
|
Change in Hemoglobin
|
1.08 mg/dl
Standard Error 0.484
|
1.20 mg/dl
Standard Error 0.491
|
Adverse Events
Intervention Cases
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place