Intrarectal Misoprostol in Postpartum Haemorrhage

Phase 3

Completed

• Conditions: Postpartum Haemorrhage
• Interventions: Drug: Placebo; Drug: Misoprostol

• Registration Number: NCT01116050
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2007-12
• Study First Submitted: 2010-05-03
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-04
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-19
• Last Update Posted: 2011-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 116

Inclusion Criteria

• Older than 18 yrs old
• Giving birth after 32 Weeks of amenorrhea
• Post-partum haemorrhage due to atony
• Inefficiency off the first line treatment
• Written signed consent form

Exclusion Criteria

• known allergy to prostaglandin
• haemostasis anomalies before labour
• anticoagulant treatment
• fetal death
• accreta or percreta placenta
• under 18 years
• delivery before 32 weeks of amenorrhea
• post-partum bleeding not suspected to be due to atonic uterus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
MISOPROSTOL	Misoprostol	-

Primary Outcome Measures

Name	Time	Method
quantification of blood loss	15 minutes after treatment administration	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

Secondary Outcome Measures

Name	Time	Method
Sulprostone Requirement	30 minutes after the diagnostic of post-partum hemorrhage	distribution of blood loss over time, blood loss higher than 500mL after treatment, blood transfusion, changes in haemoglobin concentration and haematocrit levels, recourse to sulprostone, uterine arteries embolizations and hysterectomy