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Oxytocin

Pitocin, Syntocinon

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Studies 93
Trials 100
Completed PHASE3 INTERVENTIONAL NCT01116050

Intrarectal Misoprostol in Postpartum Haemorrhage

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

Postpartum haemorrhage (PPH) remains the major cause of maternal mortality in France. The most efficient treatment of severe PPH is sulprostone which is associated with cardiac complications. The objective of this study was to assess the efficacy and the safety of intrarectal misoprostol for curative postpartum haemorrhage treatment. We conducted a multicenter double blind randomized placebo control trial between June 2004 and December 2007, among consenting women with postpartum haemorrhage and failure to oxytocin treatment. Our main criteria of judgement was quantification of blood loss and the use of sulprostone between the two groups using either misoprostol intrarectal tablets (5X200mg ) or placebo in similar opaque introducer.

Interventions

Name: Misoprostol
Type: DRUG
Description: 5 tablets of 200 microgram geach intra rectal by opaque introducer
Name: Placebo
Type: DRUG
Description: 5 tablets in opque introducer

Primary Outcomes

Measure: quantification of blood loss
TimeFrame: 15 minutes after treatment administration
Description: quantification of blood loss and the use of sulprostone between the two groups using either misoprostol intrarectal tablets (5X200mg ) or placebo in similar opaque introducer

Trial Information

NCT ID

NCT01116050

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE3

Sponsor

University Hospital, Caen

Last Updated

December 15, 2025