drugset / Trial / NCT00790062
Oxytocin Regimen to Prevent Atony and Postpartum Hemorrhage During Vaginal Delivery: 3-arm RCT
Phase 4
Completed
1798 enrolled
University of Alabama at Birmingham
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2008-11
- Primary completion
- 2010-06
- Completion
- 2010-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oxytocin | Peptide | 10 iu | — |
| Subject | Oxytocin | Peptide | 40 iu | — |
| Subject | Oxytocin | Peptide | 80 iu | — |