Ergometrine Versus Oxytocin in the Management of Atonic Post-partum Haemorrhage (PPH) in Women Delivered Vaginally

What Was Tested

The trial (phase 3) is built around Oxytocin.

200 women with PPH will be randomly divided into 2 equal groups using computer generated random numbers.

The investigators will not include a control group for ethical reasons.

It had two arms (groups): Ergometrine (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.

All patients attending the labour ward will be invited to participate in the study, the invitation will include a clear full explanation of the study.

Who Took Part

The registry lists 200 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.

The full record lists 1 inclusion and 2 exclusion criteria; among the exclusions: gestational age\<37 weeks; hypertension, cardiac disease or preeclampsia.

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.

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

Those kept unaware of assignments: participant and investigator.

It started in 2014-11 with completion listed for 2017-10.

It ran at 2 sites in Egypt (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 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 in 200 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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