Intrarectal Misoprostol in Postpartum Haemorrhage (HEMOSTOP)
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.
|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|
- 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
- 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
|Study Start Date:||January 2004|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo||
5 tablets in opque introducer
5 tablets of 200 microgram geach intra rectal by opaque introducer
Please refer to this study by its ClinicalTrials.gov identifier: NCT01116050
|Principal Investigator:||Michel DREYFUS, MD, PhD||University Hospital, Caen|