Misoprostol and Oxytocin in Uniject® for Postpartum Hemorrhage Prevention in Communities

What Was Tested

In this phase 3 trial, researchers set out to test Oxytocin.

It had two arms (groups): Group 1 (experimental) and Group 2 (experimental).

The registry classes the interventions as drug.

More on the Plan

The most common cause of PPH is uterine atony (failure of the uterus to contract properly after childbirth).

However, it is not always feasible to administer parenteral Oxytocin in resource-poor settings given the cold storage, sterile equipment, skilled personnel, and administration requirements.

Study Design: The study is designed as a community-based cluster Randomised Control Trial.

Informed consent /Enrollment: Women will be approached by trained study staff in the third trimester or when they present for delivery and asked if they wish to participate in the study.

Who Took Part

It was open to women only.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Pregnant women planning vaginal delivery with a trained study provider at a PHC who are eligible to participate in research according to national guidelines and able to provide informed consent.

The full record lists 1 inclusion and 3 exclusion criteria; among the exclusions: women not delivering in study catchment area with a trained study provider will not be eligible to participate in the trial; women with known contraindications to prostaglandins, including misoprostol will also be excluded; women delivering in a facility that currently routinely administers prophylactic oxytocin to women in the third stage labor will also be excluded.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

The Oxytocin group and the comparison group ran side by side rather than switching.

In this single-blind Oxytocin study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2013-07 with completion listed for 2014-12.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Mean change in Pre- and post-delivery Haemoglobin (time frame: 18 months).

It also tracked 4 secondary outcomes, for example Safety and Programmatic feasibility.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Oxytocin in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.