drugset / Trial / NCT01116050

Intrarectal Misoprostol in Postpartum Haemorrhage

NCT01116050

Phase 3 Completed 116 enrolled University Hospital, Caen
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2004-01
Primary completion
2007-12
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Misoprostol Other / unclassified 1000 ug Intrathecal

Indications

No indication recorded.