NCT01116050

Intrarectal Misoprostol in Postpartum Haemorrhage

Second-line Treatment of Post-partum Haemorrhage With Intrarectal Misoprostol: a Multicentre, Double Blind, Randomized Placebo-controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postpartum Haemorrhage

Interventions

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

Timeline

• Start date: 2004-01-01
• Primary completion: 2007-12-01
• First posted: 2010-05-04
• Last updated: 2011-05-20