HEMOSTOP: Intrarectal Misoprostol in Postpartum Haemorrhage

• Sponsor: University Hospital, Caen (Other)
• Overall Status: Completed
• CT.gov ID: NCT01116050
• Collaborator: (none)
• Enrollment: 116
• Arms: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postpartum Haemorrhage	Drug: Misoprostol; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 116 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Second-line Treatment of Post-partum Haemorrhage With Intrarectal Misoprostol: a Multicentre, Double Blind, Randomized Placebo-controlled Trial
• Study Start Date: Jan 1, 2004
• Actual Primary Completion Date: Dec 1, 2007

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University Hospital, Caen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01116050
• Other Study ID Numbers: 03-104; 03-104
• First Posted: May 4, 2010
• Last Update Posted: May 20, 2011
• Last Verified: May 1, 2011

• Additional relevant MeSH terms: Postpartum Hemorrhage; Hemorrhage; Misoprostol

Study Results

No Results Posted as of May 20, 2011