Study Results
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Basic Information
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COMPLETED
PHASE3
116 participants
INTERVENTIONAL
2004-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
5 tablets in opque introducer
MISOPROSTOL
Misoprostol
5 tablets of 200 microgram geach intra rectal by opaque introducer
Interventions
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Misoprostol
5 tablets of 200 microgram geach intra rectal by opaque introducer
Placebo
5 tablets in opque introducer
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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University Hospital, Caen
OTHER
Responsible Party
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Caen University Hospital
Principal Investigators
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Michel DREYFUS, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Caen
References
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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.
Other Identifiers
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03-104
Identifier Type: -
Identifier Source: secondary_id
03-104
Identifier Type: -
Identifier Source: org_study_id
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