Misoprostol in the Treatment of Postpartum Hemorrhage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Postpartum Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Misoprostol

three tablets of active misoprostol (600 mcg) given sublingually

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

600 mcg of sublingual misoprostol

Placebo

three tablets resembling misoprostol given sublingually

Group Type PLACEBO_COMPARATOR

Misoprostol

Intervention Type DRUG

600 mcg of sublingual misoprostol

Interventions

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Misoprostol

600 mcg of sublingual misoprostol

Intervention Type DRUG

Eligibility Criteria

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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)

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No