Intrarectal Misoprostol in Postpartum Haemorrhage

NCT01116050 | Completed Phase 3 DMC

• 1 other identifier: 03-104
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postpartum Haemorrhage

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Sulprostone Requirement

  30 minutes after the diagnostic of post-partum hemorrhage

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

MISOPROSTOL

EXPERIMENTAL

Drug: Misoprostol

Interventions

Misoprostol DRUG

5 tablets of 200 microgram geach intra rectal by opaque introducer

MISOPROSTOL

Placebo DRUG

5 tablets in opque introducer

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Related Publications (1)

• Parry Smith WR, Papadopoulou A, Thomas E, Tobias A, Price MJ, Meher S, Alfirevic Z, Weeks AD, Hofmeyr GJ, Gulmezoglu AM, Widmer M, Oladapo OT, Vogel JP, Althabe F, Coomarasamy A, Gallos ID. Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2020 Nov 24;11(11):CD012754. doi: 10.1002/14651858.CD012754.pub2.

  PMID: 33232518 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Michel DREYFUS, MD, PhD

  University Hospital, Caen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 3, 2010
• First Posted: May 4, 2010
• Study Start: January 1, 2004
• Primary Completion: December 1, 2007
• Last Updated: May 20, 2011

Record last verified: 2011-05