Intrarectal Misoprostol in Postpartum Haemorrhage (HEMOSTOP)

May 19, 2011 updated by: University Hospital, Caen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
5 tablets in opque introducer
EXPERIMENTAL: MISOPROSTOL
Drug: Misoprostol
5 tablets of 200 microgram geach intra rectal by opaque introducer

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Investigators

  • Principal Investigator: Michel DREYFUS, MD, PhD, University Hospital, Caen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

May 3, 2010

First Submitted That Met QC Criteria

May 3, 2010

First Posted (ESTIMATE)

May 4, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 20, 2011

Last Update Submitted That Met QC Criteria

May 19, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postpartum Haemorrhage

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe