Comparing Misoprostol and Oxytocin in UnijectTM for Postpartum Hemorrhage (PPH) Prevention in Mali

Gynuity Health Projects

Overview

This is a large, community-based, cluster-randomized trial to compare routine prophylactic use of 600 mcg oral misoprostol and 10 IU oxytocin delivered by UnijectTM intramuscularly during the third stage of labor.

This study will assess the programmatic implications (including feasibility, acceptability, costs, risks and benefits) at the community level of the introduction of misoprostol and/or oxytocin in UnijectTM for the prevention of PPH and will help to identify the appropriate niche for both drugs.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Conditions

Postpartum Hemorrhage

Interventions

misprostolDRUG

600 mcg misoprostol oral

UnijectTMDEVICE

10 IU oxytocin delivered intramuscularly with UnijectTM

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * women delivering at home with a trained study provider who are able to provide informed consent Exclusion Criteria: * women with known contraindications to prostaglandins

Locations (1)

Villages in Mopti

Mopti, Mali

Outcomes

Primary Outcomes

Mean change in hemoglobin

To establish the comparable effectiveness of two technologies, individual pre- and post-delivery Hb measures will be taken to calculate change in Hb. This will be done using a Hemocue Hemoglobin machine + cuvette (HemoCue, Angelholm, Sweden). The Hemocue is a simple means of collecting Hb measures at the community-level where traditional laboratory techniques are not feasible.

Time frame: during 3rd trimester and 1-3 days postpartum

Secondary Outcomes

occurrence and management of side effects

nausea, vomiting, diarrhea, shivering, fever

Time frame: 1 hour postpartum

correct timing of drug administration

administration of the drug after the birth of the baby and verifying no twin, before the expulsion of the placenta

Time frame: collected immediately following birth, verified 1-3 days postpartum

change in hemoglobin ≥ 2 g/dL

Time frame: during third trimester and 1-3 days postpartum

additional interventions

use of additional uterotonics, manual removal of placental fragments, etc

Time frame: during birth and 1-3 days postpartum

referrals

referral requested, transfers carried out, reasons for incomplete referrals/transfers

Time frame: 1-3 days postpartum

acceptability

acceptability according to woman of study medication, care received, side effects experienced

Time frame: 1-3 days postpartum

Data from ClinicalTrials.gov

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