Intrarectal Misoprostol in Postpartum Haemorrhage

Study Overview
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Brief Summary
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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.

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

Conditions
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Postpartum Haemorrhage

Intervention / Treatment
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* Drug: Misoprostol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 5 tablets in opque introducer<br>|
| Experimental: MISOPROSTOL<br> | Drug: Misoprostol<br>* 5 tablets of 200 microgram geach intra rectal by opaque introducer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quantification of blood loss | 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 | 15 minutes after treatment administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sulprostone Requirement | 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 | 30 minutes after the diagnostic of post-partum hemorrhage |