Carbetocin Versus Oxytocin in the Prevention of Post Partum Haemorrhage (PPH) in Women Delivered Vaginally With at Least 2 Risk Factors for Atonic PPH: A Randomised Controlled Trial

What Was Tested

This registered phase 3 trial tested Oxytocin and Carbetocin.

250 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

Enrollment: 200 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 at least 2 risk factors for developing PPH. Risk factors include previous PPH, BMI\>35, multiple pregnancy, prolonged labour \>12 hours, ultrasound estimated fetal weight\>4kg and induction of labour.

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

How the Study Was Run

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

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2014-11 with completion listed for 2015-07.

It ran at 2 sites in Egypt (2).

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Need for other uterotonics (time frame: 2 minutes after giving the drug).

What This Means in Plain Language

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