Intrarectal Misoprostol in Postpartum Haemorrhage

Postpartum Haemorrhage Clinical Trial

— HEMOSTOP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01116050
• Other study ID #: 03-104
• Secondary ID: 03-104
• Status: Completed
• Phase: Phase 3
• First received: May 3, 2010
• Last updated: May 19, 2011
• Start date: January 2004

Study information

• Verified date: May 2011
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Haemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• Misoprostol
5 tablets of 200 microgram geach intra rectal by opaque introducer
• Placebo
5 tablets in opque introducer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No