Misoprostol for the Treatment of Postpartum Hemorrhage

What Was Tested

In this not phased trial, researchers set out to test Oxytocin.

It had two arms (groups): Misoprostol (experimental) and Oxytocin (active comparator).

The registry classes the interventions as drug.

More on the Plan

Misoprostol offers several advantages over oxytocin and ergometrine, the drugs currently used to treat PPH.

For example, misoprostol is stable at high temperatures and has a shelf life of several years, it is easy to administer, it can be given to hypertensive patients, and it is inexpensive.

Blood loss will be measured for all consenting women who deliver vaginally.

This study will take place in hospitals located in Burkina Faso, Ecuador, Egypt, Turkey, and Vietnam.

Who Took Part

The registry lists 1786 actual participants took part.

It was open to women only.

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

Examples of who could join: Postpartum hemorrhage due to suspected uterine atony. Depending on study group: administration of prophylactic uterotonics in third stage of labor.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: known allergy to misoprostol or other prostaglandin; C-section for current delivery.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2005-07 with completion listed for 2008-01.

It ran at 6 sites in Egypt (2), Burkina Faso (1), Ecuador (1), Turkey (Türkiye) (1) and Vietnam (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Need for additional treatment after initial PPH study treatment (time frame: all additional interventions recorded following initial uterotonic treatment).

It also tracked 6 secondary outcomes, for example Mean blood loss after PPH treatment, Change in hemoglobin from pre-delivery to postpartum, Time to bleeding cessation, Blood transfusion, Side effects and Acceptability for women.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 1786 people.

With 1786 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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