Carbetocin Versus Oxytocin in the Management of Atonic Post Partum Haemorrhage (PPH) in Women Delivered Vaginally: A Randomised Controlled Trial

What Was Tested

This registered phase 3 trial tested Oxytocin and 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 Oxytocin (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

The registry lists 100 actual participants took part.

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

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.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2013-05 with completion listed for 2014-12.

It ran at 2 sites in Egypt (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 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 Oxytocin and Carbetocin in 100 people.

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

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