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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01116050

Acronym

HEMOSTOP

Enrollment

116

Registered

2010-05-04

Start date

2004-01-31

Completion date

Unknown

Last updated

2011-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Haemorrhage

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.

Interventions

DRUGMisoprostol

5 tablets of 200 microgram geach intra rectal by opaque introducer

DRUGPlacebo

5 tablets in opque introducer

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026