Carbetocin Versus Ergometrine in the Management of Atonic Post Partum Haemorrhage (PPH) in Women Delivered Vaginally

What Was Tested

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

200 women will be randomly divided into 2 equal groups using computer generated random numbers.

It had two arms (groups): Carbetocin (active comparator) and Ergometrine (active comparator).

The registry classes the interventions as drug.

More on the Plan

Risk factors of atonic PPH include multiple pregnancy, placenta previa, previous PPH, body mass index (BMI) \>30, prolonged labour, fetal macrosomia\>4kg and primipara\> 40 years.

Oxytocin is currently the uterotonic of first choice.

A disadvantage of oxytocin is its short half-life of 4-10 min, regularly requiring a continuous intravenous infusion or repeated intramuscular injections.

Carbetocin has a rapid onset of action (within 1-2 min) and a prolonged duration of action (approximately 1 h) because of sustained uterine response with contractions of higher amplitude and frequency.

Who Took Part

200 planned participants were the target.

It was open to women only aged from 20 years up to 40 years.

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

Examples of who could join: Women with atonic PPH.

The full record lists 1 inclusion and 6 exclusion criteria; among the exclusions: gestational age \<37 weeks; cardiac, renal or liver diseases; known hypersensitivity to carbetocin.

How the Study Was Run

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

The participants were allocated by chance, so the Carbetocin 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 Carbetocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2015-04 with completion listed for 2017-03.

It ran at 2 sites in Egypt (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Need for other uterotonics (time frame: 2 minutes after giving the drug).

It also tracked 1 secondary outcome, for example Development of major PPH.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Carbetocin in 200 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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