Oxytocin Via Intramuscular Injection and Intravenous Bolus or Infusion for Prevention of Postpartum Hemorrhage

What Was Tested

This registered not phased trial tested Oxytocin.

It had three arms (groups): IV infusion (active comparator), IV bolus (active comparator) and IM injection (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 4983 actual participants took part.

It was open to women only aged from 18 years up to 45 years.

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

The full record lists 1 inclusion and 3 exclusion criteria; among the exclusions: planned or transferred for delivery via cesarean section; administration of a pre-delivery uterotonic to induce or augment labor; unable to provide informed consent due to mental impairment, distress during labor or other reason.

How the Study Was Run

It was run as a randomized, parallel-group and open-label 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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2014-04 with completion listed for 2015-09.

It ran at 2 sites in Egypt (2).

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Proportion of women with postpartum blood loss equal to or greater than [amount hidden].

It also tracked 7 secondary outcomes, for example Mean postpartum blood loss, Mean change in hemoglobin pre-delivery to postpartum, Time to delivery of placenta, Administration of additional oxytocin, other uterotonics or other interventions such as blood transfusion or hysterectomy and Side effects 1 hour postpartum.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 4983 people.

With 4983 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.