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

Gynuity Health Projects

Status and phase: Completed; Phase 4

Conditions: Postpartum Hemorrhage

Treatments: Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT02226588

3004

Details and patient eligibility

About

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.

Enrollment: 2,827 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,827 participants in 2 patient groups

Secondary prevention

Experimental group

Description:

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

Treatment:

Drug: Misoprostol

Universal prophylaxis

Active Comparator group

Description:

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

Treatment:

Drug: Misoprostol