Treatment of Postpartum Haemorrhage (PPH) Using Misoprostol in Home Births

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

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-12-31

Brief Summary

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A double-blind individual randomized controlled study of misoprostol vs. placebo for treatment in homebirths in the Chitral district, in the Khyber Pakhtunkhwa province in Pakistan.

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Detailed Description

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A double-blind individual randomized controlled study of misoprostol vs. placebo for treatment in homebirths in the Chitral district, in the Khyber Pakhtunkhwa province in Pakistan. The purpose of the study is to assess the overall clinical and programmatic effectiveness of Traditional Birth Attendants (TBAs) administering 800 mcg sublingual misoprostol to treat Postpartum Haemorrhage (PPH) at the community level.

The study will recruit pregnant women who deliver at home. All women enrolled in the study will receive misoprostol for prevention (600 mcg oral dose). Women diagnosed with PPH will be randomized to receive either a) standard care + 800 mcg sublingual misoprostol (four 200 mcg tablets) or b) standard care + four placebo tablets resembling misoprostol. In this setting, standard care is uterine massage and/or compression and referral to the nearest health facility or attendance by the Lady Health Visitor/ Community Health Nurse.

Conditions

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Postpartum Haemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Misoprostol

women who experience a PPH will be randomized to receive 800 misoprostol (four tablets of 200 mcg administered sublingually)

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

4 tablets of 200 mcg misoprostol administered sublingually if the woman experiences a PPH after child birth

placebo

women who experience a PPH will be randomized to receive 4 placebo tablets administered sublingually

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

4 tablets, administered sublingually if the woman experiences a PPH

Interventions

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Misoprostol

4 tablets of 200 mcg misoprostol administered sublingually if the woman experiences a PPH after child birth

Intervention Type DRUG

placebo

4 tablets, administered sublingually if the woman experiences a PPH

Intervention Type OTHER

Other Intervention Names

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Gymiso Gymiso

Eligibility Criteria

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Inclusion Criteria

* Women who deliver at home with a study TBA present.
* Women must be willing and able to provide informed consent
* Women must agree to participate in a follow up interview
* Women must agree to have pre and post-partum haemoglobin taken

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes