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Intrarectal Misoprostol in Postpartum Haemorrhage (HEMOSTOP)

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT01116050
First received: May 3, 2010
Last updated: May 19, 2011
Last verified: May 2011
History of Changes
  Purpose

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 Intervention Phase
Postpartum Haemorrhage
 Drug: Misoprostol
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Postpartum Care
Drug Information available for: Misoprostol
U.S. FDA Resources

Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:
  • quantification of blood loss [ Time Frame: 15 minutes after treatment administration ] [ Designated as safety issue: No ]
    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:
  • Sulprostone Requirement [ Time Frame: 30 minutes after the diagnostic of post-partum hemorrhage ] [ Designated as safety issue: No ]
    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


Enrollment: 116
Study Start Date: January 2004
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01116050

Sponsors and Collaborators
University Hospital, Caen
Investigators
Principal Investigator: Michel DREYFUS, MD, PhD University Hospital, Caen
  More Information

No publications provided

Responsible Party: Monsieur Angel PIQUEMAL, Caen University Hospital
ClinicalTrials.gov Identifier: NCT01116050     History of Changes
Other Study ID Numbers: 03-104, 03-104
Study First Received: May 3, 2010
Last Updated: May 19, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Misoprostol
Anti-Ulcer Agents
 Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on May 16, 2013