IV Versus IM Administration of Oxytocin for Postpartum Bleeding

What Was Tested

The trial (phase 4) is built around Oxytocin.

It had two arms (groups): IV Infusion (active comparator) and IM administration (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 543 actual participants took part.

It was open to women only.

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

Examples of who could join: She is present to give birth to a live fetus. Willing to participate in the study. Able to give informed consent.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: scheduled for a cesarean; reject the placement of an iv during labor (for intravenous infusion); cannot give informed consent for any reason.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

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

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

Those kept unaware of assignments: participant and care provider.

It started in 2016-12-01 with completion listed for 2017-09-30.

It ran at 1 site in Argentina.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Amount of blood loss (mL) (time frame: 1 hour postpartum).

It also tracked 7 secondary outcomes, for example Average change in hemoglobin level, Average time required until expulsion of the placenta, Proportion who needed additional Interventions, Side effects, Blood pressure and Heart rate.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 543 people.

With 543 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.