A Randomized Trial Comparing Oxytocin and Oxytocin + Ergometrine for Prevention of Postpartum Haemorrhage at Caesarean Section

What Was Tested

In this not phased trial, researchers set out to test Oxytocin.

It had two arms (groups): Oxytocin arm (active comparator) and Oxytocin + syntometrine (experimental).

Oxytocin alone administered which is current standard of care.

Oxytocin plus syntometrine administered.

The registry classes the interventions as drug.

Who Took Part

540 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

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

Examples of who could join: Pregnant women delivering by caesarean section older than 18 years willing and able to give informed consent.

The full record lists 1 inclusion and 13 exclusion criteria; among the exclusions: • women not willing or women not able to provide consent; women who have a classical caesarean section; women younger than 18 years of age.

How the Study Was Run

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

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, care provider and investigator.

It started in 2014-01-01 with completion listed for 2014-06-30.

It ran at 1 site in South Africa.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Blood loss (time frame: 60 minutes).

It also tracked 3 secondary outcomes, for example Side effects of oxytocin compared to oxytocin + ergometrine, Need for additional uterotonics and Number of units blood transfused.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 540 people.

With 540 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 Oxytocin compound page, all human trials.