Misoprostol in the Treatment of Postpartum Hemorrhage

Not Applicable

Completed

• Conditions: Postpartum Hemorrhage
• Interventions: Drug: Misoprostol

• Registration Number: NCT00116480
• Lead Sponsor: Gynuity Health Projects

Brief Summary

Postpartum haemorrhage (PPH) remains a leading cause of maternal mortality, despite treatment with conventional methods. Uncontrolled reports and three small randomised controlled trials have suggested that misoprostol may have an additive effect to routine treatment, and there is a serious danger that this method will be used widely without research to document the effectiveness or risks of this method. In this randomised controlled trial (RCT), we propose to test whether 600 μg of sublingually administered misoprostol in women requiring additional uterotonics after delivery, and after routine syntocinon to all women during or after delivery, has additional effects above the additional conventional uterotonics in reducing PPH. Women with measured blood loss greater than or equal to 500 mls in 4 Karachi hospitals who give consent will be given locally routine treatment for PPH. In addition, they will be enrolled by drawing the next of a series of randomised treatment packs containing misoprostol or placebo. The primary outcome measure will be blood loss greater than or equal to 500 mls after enrolment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-06-29
• Study First Submitted QC: 2005-06-29
• Study First Posted: 2005-06-30
• Study Start: 2005-12
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-17
• Last Update Posted: 2009-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 61

Inclusion Criteria

• All women delivering vaginally with clinically diagnosed PPH requiring uterotonics

Exclusion Criteria

• Refusal to give consent for participation or if the woman is too distressed to give consent
• Woman is not entitled to give informed consent (e.g. minors without a guardian)
• Woman who had a caesarean section
• Delivery is regarded as abortion (gestational age < 28 weeks)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Misoprostol	three tablets resembling misoprostol given sublingually
Misoprostol	Misoprostol	three tablets of active misoprostol (600 mcg) given sublingually

Primary Outcome Measures

Name	Time	Method
Blood loss greater than or equal to 500 mls after enrolment	Blood loss measured for minimum of 1 hour or until active bleeding ceased

Secondary Outcome Measures

Name	Time	Method
Side effects	observed or reported following study treatment and prior to discharge
Average blood loss	Blood loss measured for minimum of one hour or until active bleeding ceased
Clinical complications (need for transfusion, hysterectomy)	After delivery and prior to hospital discharge
Pre-delivery and post-delivery hemoglobin measures	Pre-delivery hemoglobin measured upon admission to hospital (during labor) and measured postpartum 12-24 hours after delivery

Trial Locations

Locations (2)

Aga Khan University Hospital; 🇵🇰 Karachi, Pakistan

The Aga Khan Health Services; 🇵🇰 Karachi, Pakistan