Intrarectal Misoprostol in Postpartum Haemorrhage

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.

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Key information

Conditions

Postpartum Haemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postpartum Hemorrhage Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

5 tablets of 200 microgram geach intra rectal by opaque introducer

Placebo

Drug

5 tablets in opque introducer

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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

Acronym: HEMOSTOP

Important dates

Study start: 2004
Primary completion: 2007
First posted: May 4, 2010
Registry last updated: May 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed