Oxytocin Versus, Sublingual Misoprostol in the Secondary Prevention of Postpartum Hemorrhage After Vaginal Delivery

What Was Tested

This registered not phased trial tested Oxytocin.

It had two arms (groups): oxytocin (active comparator) and misoprostol (experimental).

The registry classes the interventions as drug.

More on the Plan

When prophylaxis fails and PPH develops, it is advised that uterotonic medicines be used as first-line therapy.

However, it's unclear whether the uterotonic drug is better for treating PPH as first-line therapy.

Who Took Part

The registry lists 150 planned participants were the target.

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

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 1 inclusion and 6 exclusion criteria; among the exclusions: \<37 weeks of pregnancy,; genital tract injuries,; coagulation deficit,.

How the Study Was Run

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

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

The Oxytocin group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2021-11-01 with completion listed for 2023-10-31.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): measured excessive bleeding blood loss ≥ 300 mills after PPH treatment (time frame: 24 hours).

It also tracked 2 secondary outcomes, for example change in hemoglobin and need for additional interventions.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 150 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.