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Intrarectal Misoprostol in Postpartum Haemorrhage (HEMOSTOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01116050
Recruitment Status : Completed
First Posted : May 4, 2010
Last Update Posted : May 20, 2011
Sponsor:
Information provided by:

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  (Clinical Trial)
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 : January 2004
Primary Completion Date : December 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol
U.S. FDA Resources

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 [ Time Frame: 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 [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01116050


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

Responsible Party: Monsieur Angel PIQUEMAL, Caen University Hospital
ClinicalTrials.gov Identifier: NCT01116050     History of Changes
Other Study ID Numbers: 03-104
First Posted: May 4, 2010    Key Record Dates
Last Update Posted: May 20, 2011
Last Verified: May 2011

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