Carbetocin Versus Oxytocin in the Prevention of Post Partum Haemorrhage (PPH) in Women Undergoing Caesarean Sections for Placenta Previa: A Randomised Controlled Trial

What Was Tested

This registered phase 3 trial tested Oxytocin and Carbetocin.

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.

Placenta praevia exists when the placenta is inserted wholly or in part into the lower segment of the uterus.

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.

Who Took Part

The registry lists 500 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 undergoing CS for placenta previa.

The full record lists 1 inclusion and 7 exclusion criteria; among the exclusions: gestational age \<37 weeks; cardiac, renal or liver diseases; need for general anaesthesia.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

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

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

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

It started in 2014-11 with completion listed for 2017-11.

It ran at 2 sites in Egypt (2).

Its stated primary purpose is prevention.

What Was Measured

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

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

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Oxytocin and Carbetocin in 500 people.

With 500 participants it is a large trial for this field.

Its status is unknown; 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.