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

Gynuity Health Projects2,827 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

2,827

Conditions

Postpartum Hemorrhage

Interventions

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Primary Health Care Units

Damanhur, El Beheira, Egypt

Primary Health Care Units

Kafr El Dawar, El Beheira, Egypt

Outcomes

Primary Outcomes

Mean drop in pre- to post-delivery hemoglobin level

Hemoglobin will be measured by primary health unit staff using a portable handheld Hemocue machine.

Time frame: Pre-delivery hemoglobin will be measured during a third trimester antenatal care visit or during early labor. Post-delivery hemoglbin will be measured 2 to 4 days after delivery of the baby.

Secondary Outcomes

Proportion of women transferred to higher level care

The proportion of women transferred to higher level care will be assessed. Includes the condition of woman at time of transfer and arrival at transfer facility.

Time frame: Following delivery to postpartum visit (2 to 4 days after delivery)

Proportion of women diagnosed with PPH

PPH will be diagnosed using the standard practices of PHU staff

Time frame: After delivery of the baby up to 24 hours postpartum

Proportion of women receiving additional interventions for PPH

An additional intervention could include: uterotonics, manual removal of placental fragments. bimanual compression, IV fluids given to control active bleeding.

Time frame: Following delivery to postpartum visit (2 to 4 days after delivery)

Proportion of women who experience side effects

Women experiencing known side effects of misoprostol, including shivering/chills and pyrexia; severity, duration, and any additional care provided will be assessed

Time frame: From time of delivery to 2 hours postpartum

Proportion of women who find the intervention acceptable

Acceptability will be assessed in an exit interview with women - women will be asked if they are willing to take misoprostol in future deliveries and about the preferences what method they would prefer (primary or secondary prevention) in future deliveries.

Time frame: Measured at postpartum visit (2 to 4 days after delivery)

Proportion of women who receive intervention per protocol

To assess feasibility, we will document the proportion of women for whom the intervention arm protocol is correctly followed (including correct timing of drug administration, when necessary).

Time frame: within 2 hours of delivery

Proportion of women experiencing a serious adverse event

Serious adverse events include hysterectomy, blood transfusion, maternal death

Time frame: Within 2 to 4 days after delivery