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

Outcome

Missed primary endpoint

registry p = 0.670; Risk Ratio (RR) 1.00 (95% CI 0.63 to 1.59); ANCOVA NCT00790062 ↗

paper 80 units or 40 units of prophylactic oxytocin did not reduce overall postpartum hemorrhage treatment PMID 22227638 ↗

Publications

Results Tita AT, Szychowski JM, Rouse DJ, Bean CM, Chapman V, Nothern A, Figueroa D, Quinn R, Andrews WW, Hauth JC. Higher-dose oxytocin and hemorrhage after vaginal delivery: a randomized controlled trial. Obstet Gynecol. 2012 Feb;119(2 Pt 1):293-300. doi: 10.1097/AOG.0b013e318242da74.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Oxytocin	Peptide	10 iu	—
Subject	Oxytocin	Peptide	40 iu	—
Subject	Oxytocin	Peptide	80 iu	—