A prospective randomised trial to compare the efficacy and safety of hemabate and syntometrine for the prevention of primary postpartum haemorrhage.

What Was Tested

The paper reports a study of Carboprost, published as a randomized controlled trial.

The study was set in a district general hospital with approximately 4,000 deliveries annually.

The study was discontinued at the time of the interim analysis because of unacceptable gastrointestinal side effects.

Who Took Part

According to the abstract, 529 women were involved.

PubMed indexes the participants as adults, women only.

How the Study Was Run

The design is described as randomized, single-blind, open-label and parallel-group.

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

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

Being open-label, the Carboprost study did not mask who received what.

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

What Was Measured

The study was discontinued at the time of the interim analysis because of unacceptable gastrointestinal side effects.

In a pre-specified subgroup analysis, women delivered vaginally were further subdivided into those considered to be at high or low risk of primary PPH.

The subject headings attached to it are Blood Pressure, Body Height, Carboprost, Cesarean Section, Dinoprost, Disease Susceptibility and Drug Combinations.

What This Means in Plain Language

The paper is a randomized, single-blind and open-label study of Carboprost in 529 women.

With several hundred people or more, it is a fairly large study for this kind of research.

The publication is from 2001 (Prostaglandins & other lipid mediators), a journal based in United States.

More context: all human trials.