Combined Use of Oxytocin and Misoprostol in the Prevention of Post Partum Haemorrhage

Phase 4 Terminated 1721 enrolled Assistance Publique - Hôpitaux de Paris URC-CIC Paris Descartes Necker Cochin · collab

RandomizedParallel-groupDouble-blindPrevention

Summary

To demonstrate that the combined used of oxytocin and misoprostol prevent from post partum haemorrhage better than oxytocin alone, following vaginal birth at 36 to 42 weeks.

Timeline

Start: 2010-03
Primary completion: 2014-07
Completion: 2014-12

Outcome

Missed primary endpoint

Stopped: “reason of halt prematurely: futility of the trial”

paper The rate of postpartum hemorrhage was 8.4% (68/806) in the misoprostol and 8.3% (66/797) in the placebo group (P=.98) PMID 27607864 ↗

Publications

Results Quibel T, Ghout I, Goffinet F, Salomon LJ, Fort J, Javoise S, Bussieres L, Aegerter P, Rozenberg P; Groupe de Recherche en Obstetrique et Gynecologie (GROG). Active Management of the Third Stage of Labor With a Combination of Oxytocin and Misoprostol to Prevent Postpartum Hemorrhage: A Randomized Controlled Trial. Obstet Gynecol. 2016 Oct;128(4):805-11. doi: 10.1097/AOG.0000000000001626.
Voillequin S, Quibel T, Rozenberg P, Rousseau A. Duration of the second and third stages of labor and risk of postpartum hemorrhage: a cohort study stratified by parity. BMC Pregnancy Childbirth. 2025 Feb 11;25(1):143. doi: 10.1186/s12884-025-07229-4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Misoprostol	Other / unclassified	400 ug	Oral