Phase 4
N=1,798
Oxytocin Regimen to Prevent Atony and Postpartum Hemorrhage During Vaginal Delivery: 3-arm RCT
Uterine Atony · Postpartum Hemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT00790062 ↗Enrolled (actual)
1,798
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcome: Primary: Number of Subjects Reporting Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment — 45; 31; 42 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oxytocin (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment |
45; 31; 42 | — |
| PRIMARY Women in Each Group With Risk Factors for Atony or Postpartum Hemorrhage |
351; 255; 333 | — |
| PRIMARY Risk to Using Increasing Doses of Oxytocin Based on Pre-specified Risk Factors |
37; 22; 28 | 0.670 |
| SECONDARY Change in Pre- to Post-delivery Hematocrit (%) |
4; 4; 4 | — |
| SECONDARY Number of Participants Experiencing Individual Treatment or Intervention in the Primary Outcome |
45; 30; 40; 7; 4; 5 | — |
| SECONDARY Number of Participants Experiencing Postpartum Hemorrhage (Clinical Estimate Greater Than 500cc) |
38; 24; 24 | — |
| SECONDARY Number of Subjects With Hospital Stays Greater Than 4 Days |
116; 95; 109 | — |
| SECONDARY Number of Subjects Requiring Hypotension Warranting Pressor Agent or Fluid Bolus |
85; 56; 95; 82; 51; 87 | — |
Summary
This is a double-blind 3-arm randomized clinical trial to determine whether higher dose oxytocin regimens (compared to the standard regimen) reduce the frequency of uterine atony and postpartum hemorrhage after vaginal delivery. Uterine atony is a loss of tone in the uterine musculature which can cause acute postpartum hemorrhage, which is the major cause of maternal mortality worldwide. Oxytocin is routinely administered postpartum in the US and effectively reduces uterine atony. The optimal dose of oxytocin for vaginal delivery is not known.
Eligibility Criteria
Inclusion Criteria
- > 24 weeks, viable pregnancy, singleton or twins
Exclusion Criteria
- No consent
- Contraindication to oxytocin
- Antepartum fetal demise
- Intrapartum use of concentrated oxytocin
- Planned cesarean
- DIC or coagulopathy
Data sourced from ClinicalTrials.gov (NCT00790062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.