Intrarectal Misoprostol in Postpartum Haemorrhage (HEMOSTOP)

Caen University Hospital

Status and phase: Completed; Phase 3

Conditions: Postpartum Haemorrhage

Treatments: Drug: Misoprostol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01116050

03-104

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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116 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

MISOPROSTOL

Experimental group

Treatment:

Drug: Misoprostol