Trial Outcomes & Findings for Oxytocin Regimen to Prevent Atony and Postpartum Hemorrhage During Vaginal Delivery: 3-arm RCT (NCT NCT00790062)
NCT ID: NCT00790062
Last Updated: 2016-04-08
Results Overview
the number of subjects with any treatment of uterineatony or hemorrhage.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1798 participants
Primary outcome timeframe
baseline to discharge (2 - 3 days)
Results posted on
2016-04-08
Participant Flow
There were 1,798 women randomized.
At planned interim review (n=1,201), enrollment in the 40-unit group was stopped for futility and enrollment continued in the other groups.
Participant milestones
| Measure |
Oxytocin 10 Units/500cc
|
Oxytocin 40 Units/500cc
Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
|
Oxytocin 80U/500cc
|
|---|---|---|---|
|
Overall Study
STARTED
|
659
|
481
|
658
|
|
Overall Study
COMPLETED
|
659
|
481
|
658
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oxytocin Regimen to Prevent Atony and Postpartum Hemorrhage During Vaginal Delivery: 3-arm RCT
Baseline characteristics by cohort
| Measure |
Oxytocin 10 Units/500cc
n=659 Participants
|
Oxytocin 40 Units/500cc
n=481 Participants
Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
|
Oxytocin 80U/500cc
n=658 Participants
|
Total
n=1798 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
Age (years)
|
23.9 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
23.9 years
STANDARD_DEVIATION 5.1 • n=7 Participants
|
24.4 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
24.2 years
STANDARD_DEVIATION 5.4 • n=4 Participants
|
|
Sex/Gender, Customized
Female
|
659 participants
n=5 Participants
|
481 participants
n=7 Participants
|
658 participants
n=5 Participants
|
1798 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
143 participants
n=5 Participants
|
97 participants
n=7 Participants
|
156 participants
n=5 Participants
|
396 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American
|
404 participants
n=5 Participants
|
278 participants
n=7 Participants
|
379 participants
n=5 Participants
|
1061 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
106 participants
n=5 Participants
|
101 participants
n=7 Participants
|
120 participants
n=5 Participants
|
327 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other (not specified)
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
3 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
659 participants
n=5 Participants
|
481 participants
n=7 Participants
|
658 participants
n=5 Participants
|
1798 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline to discharge (2 - 3 days)the number of subjects with any treatment of uterineatony or hemorrhage.
Outcome measures
| Measure |
Oxytocin 10 Units/500cc
n=659 Participants
1 dose only for prophylaxsis given over 1 hour
|
Oxytocin 40 Units/500cc
n=481 Participants
Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
1 dose only for prophylaxsis given over 1 hour
|
Oxytocin 80U/500cc
n=658 Participants
1 dose only for prophylaxsis given over 1 hour
|
|---|---|---|---|
|
Number of Subjects Reporting Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment
|
45 Participants
|
31 Participants
|
42 Participants
|
PRIMARY outcome
Timeframe: Initial hospital discharge (2-3 days)In a secondary data analysis, a parsimonious set of independent risk factors for atony or postpartum hemorrhage was established: White, Hispanic, or Other (non-Black of African American) race/ethnicity, preeclampsia, or chorioamnionitus.
Outcome measures
| Measure |
Oxytocin 10 Units/500cc
n=659 Participants
1 dose only for prophylaxsis given over 1 hour
|
Oxytocin 40 Units/500cc
n=481 Participants
Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
1 dose only for prophylaxsis given over 1 hour
|
Oxytocin 80U/500cc
n=658 Participants
1 dose only for prophylaxsis given over 1 hour
|
|---|---|---|---|
|
Women in Each Group With Risk Factors for Atony or Postpartum Hemorrhage
|
351 participants
|
255 participants
|
333 participants
|
PRIMARY outcome
Timeframe: baseline to discharge (2-3 days)The frequency of the primary study outcome is examined in a subgroup of 939 women with risk factors for atony or postpartum hemorrhage. These risk factors are identified as White, Hispanic, or Other (non-Black or African American) race/ethnicity, chorioamnionitis, and preeclampsia.
Outcome measures
| Measure |
Oxytocin 10 Units/500cc
n=351 Participants
1 dose only for prophylaxsis given over 1 hour
|
Oxytocin 40 Units/500cc
n=225 Participants
Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
1 dose only for prophylaxsis given over 1 hour
|
Oxytocin 80U/500cc
n=333 Participants
1 dose only for prophylaxsis given over 1 hour
|
|---|---|---|---|
|
Risk to Using Increasing Doses of Oxytocin Based on Pre-specified Risk Factors
|
37 participants
|
22 participants
|
28 participants
|
SECONDARY outcome
Timeframe: During delivery hospitalization: Admission hematocrit - post-delivery hematocritchange in hematocrit from admission for delivery (baseline) to post-delivery (4 hours-1day postpartum depending on time of delivery)
Outcome measures
| Measure |
Oxytocin 10 Units/500cc
n=659 Participants
1 dose only for prophylaxsis given over 1 hour
|
Oxytocin 40 Units/500cc
n=481 Participants
Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
1 dose only for prophylaxsis given over 1 hour
|
Oxytocin 80U/500cc
n=658 Participants
1 dose only for prophylaxsis given over 1 hour
|
|---|---|---|---|
|
Change in Pre- to Post-delivery Hematocrit (%)
|
4 hematocrit difference (%)
Interval 1.0 to 8.0
|
4 hematocrit difference (%)
Interval 1.0 to 8.0
|
4 hematocrit difference (%)
Interval 1.0 to 7.0
|
SECONDARY outcome
Timeframe: prior to dischargethe number of individuals with each of the component treatments or individual outcomes in the primary composite.
Outcome measures
| Measure |
Oxytocin 10 Units/500cc
n=659 Participants
1 dose only for prophylaxsis given over 1 hour
|
Oxytocin 40 Units/500cc
n=481 Participants
Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
1 dose only for prophylaxsis given over 1 hour
|
Oxytocin 80U/500cc
n=658 Participants
1 dose only for prophylaxsis given over 1 hour
|
|---|---|---|---|
|
Number of Participants Experiencing Individual Treatment or Intervention in the Primary Outcome
Any Uterotonic
|
45 Participants
|
30 Participants
|
40 Participants
|
|
Number of Participants Experiencing Individual Treatment or Intervention in the Primary Outcome
Blood Transfusion
|
7 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants Experiencing Individual Treatment or Intervention in the Primary Outcome
Surgical
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Experiencing Individual Treatment or Intervention in the Primary Outcome
Other-Tamponade
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Experiencing Individual Treatment or Intervention in the Primary Outcome
Other-Arterial embolization
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Initial hospital discharge (2-3 days)the number of individuals with a clinically estimated postpartum blood loss of 500cc or more
Outcome measures
| Measure |
Oxytocin 10 Units/500cc
n=659 Participants
1 dose only for prophylaxsis given over 1 hour
|
Oxytocin 40 Units/500cc
n=481 Participants
Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
1 dose only for prophylaxsis given over 1 hour
|
Oxytocin 80U/500cc
n=658 Participants
1 dose only for prophylaxsis given over 1 hour
|
|---|---|---|---|
|
Number of Participants Experiencing Postpartum Hemorrhage (Clinical Estimate Greater Than 500cc)
|
38 Participants
|
24 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Initial hospital discharge (2 days or more)Number of individuals with prolonged hospitalization defined as 4 days or more prior to initial hospital discharge
Outcome measures
| Measure |
Oxytocin 10 Units/500cc
n=659 Participants
1 dose only for prophylaxsis given over 1 hour
|
Oxytocin 40 Units/500cc
n=481 Participants
Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
1 dose only for prophylaxsis given over 1 hour
|
Oxytocin 80U/500cc
n=658 Participants
1 dose only for prophylaxsis given over 1 hour
|
|---|---|---|---|
|
Number of Subjects With Hospital Stays Greater Than 4 Days
|
116 Participants
|
95 Participants
|
109 Participants
|
SECONDARY outcome
Timeframe: Initial hospital discharge (2-3 days or more)number of individuals with hypotension leading to administration of a fluid bolus or vasopressor agent (medication given to raise the blood pressure)
Outcome measures
| Measure |
Oxytocin 10 Units/500cc
n=659 Participants
1 dose only for prophylaxsis given over 1 hour
|
Oxytocin 40 Units/500cc
n=481 Participants
Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
1 dose only for prophylaxsis given over 1 hour
|
Oxytocin 80U/500cc
n=658 Participants
1 dose only for prophylaxsis given over 1 hour
|
|---|---|---|---|
|
Number of Subjects Requiring Hypotension Warranting Pressor Agent or Fluid Bolus
Pressor agent (medication given to increase BP)
|
85 Participants
|
56 Participants
|
95 Participants
|
|
Number of Subjects Requiring Hypotension Warranting Pressor Agent or Fluid Bolus
Fluid bolus
|
82 Participants
|
51 Participants
|
87 Participants
|
Adverse Events
Oxytocin 10 Units/500cc
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Oxytocin 40 Units/500cc
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Oxytocin 80U/500cc
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
Alan T. N. Tita, MD
University of Alabama at Birmingham
Phone: (205) 934-9616
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60