Intrarectal Misoprostol in Postpartum Haemorrhage (HEMOSTOP)
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|ClinicalTrials.gov Identifier: NCT01116050|
Recruitment Status : Completed
First Posted : May 4, 2010
Last Update Posted : May 20, 2011
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||116 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Primary Completion Date :||December 2007|
|Placebo Comparator: Placebo||
5 tablets in opque introducer
5 tablets of 200 microgram geach intra rectal by opaque introducer
- 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
- 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
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
|Principal Investigator:||Michel DREYFUS, MD, PhD||University Hospital, Caen|