Uterotonic Efficacy of Oxytocin 2.5 Versus [amount hidden] During Caesarean Section at Mulago Hospital

What Was Tested

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

It had two arms (groups): one (active comparator) and one (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 386 actual participants took part.

It was open to women only aged from 18 years up to 40 years.

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

Examples of who could join: ASA I (Healthy patient with no systemic disease) or II ( mild to moderate systemic disease). Age between 18 to 40 years.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: • allergy to oxytocin; ruptured uterus; known risk factors for postpartum haemorrhage or uterine atony.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-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, investigator and outcomes assessor.

It started in 2011-02 with completion listed for 2011-04.

It ran at 1 site in Uganda.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Uterine tone adequacy (time frame: 2 minutes).

It also tracked 1 secondary outcome, for example Intraoperative blood loss.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 386 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, all human trials.