Carbetocin Versus Syntometrine for the Third Stage of Labour

What Was Tested

This registered phase 4 trial tested Carbetocin.

It had two arms (groups): Primi (active comparator) and Multi (active comparator).

The registry classes the interventions as drug.

More on the Plan

In comparison to oxytocin, carbetocin induces a prolonged uterine response when administered postpartum, in terms of both amplitude and frequency of contractions.

The potential advantage of intramuscular carbetocin over intramuscular oxytocin is its longer duration of action.

Its relative lack of gastrointestinal and cardiovascular side-effects should also prove advantageous compared to syntometrine and other ergot alkaloids.

Who Took Part

Enrollment: 720 planned participants were the target.

It was open to women only aged from 18 years up to 50 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Any pregnant woman expected to deliver vaginally. Age more than 21 if not married. Ability to provide informed consent.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: multiple pregnancy; patients with other risk factors for postpartum haemorrhage; patients planning to have an elective caesarean section.

How the Study Was Run

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

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

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2006-11 with completion listed for 2009-04.

It ran at 1 site in Singapore.

What Was Measured

Primary outcome: 1. Postpartum haemorrhage (less than or equal to [amount hidden]) 2. Postpartum haemorrhage (less than or equal to [amount hidden]) 3. Use of additional uterotonic therapy.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Carbetocin in 720 people.

With 720 participants it is a large trial for this field.

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

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