Comparison of Primary and Secondary Prevention of Postpartum Hemorrhage at the Community Level in Egypt

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

PHASE4

Total Enrollment

2827 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-01-31

Brief Summary

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The objective of this study is to compare two community-level strategies: either selective, early administration of 800 mcg sublingual misoprostol to women for secondary prevention of postpartum hemorrhage (PPH) or universal use of 600 mcg oral misoprostol at the time of delivery for prophylaxis of PPH. The significance of this cluster randomized non-inferiority trial is its potential to inform service delivery programs on clinical outcomes, program feasibility, cost, and acceptability of two different community models of PPH care using misoprostol.1. The study hypothesizes that a service delivery model that administers misoprostol for secondary prevention is non-inferior to a model that administers misoprostol for universal prophylaxis.

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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

PREVENTION

Blinding Strategy

NONE

Study Groups

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Secondary prevention

Single sublingual dose of 800mcg (4 tablets) misoprostol administered to women with 350-500mL postpartum blood loss as estimated using a blood absorption mat or due to deteriorating postpartum condition of the woman as determined by provider's clinical judgment

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

Universal prophylaxis

Single oral prophylactic dose of 600mcg (3 tablets) misoprostol administered to all women within 1 minute of deliver of baby

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

Interventions

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Misoprostol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Willing and able to give informed consent
* Vaginal delivery
* Agrees to participate in follow-up interview
* Agrees to have pre- and post-hemoglobin taken
* Delivery at woman's home or at the primary health unit (PHU)

Exclusion Criteria

* Too advanced into active labor to provide consent
* Known allergy to misoprostol and/or other prostaglandin
* Pregnancy complications, such as hypertension, suspected multiple pregnancy, previous caesarean section, suspected still birth, ante-partum hemorrhage, and previous complication in the third trimester

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes