Effect of Misoprostol in Reducing Post Partum Hemorrhage After Labor Induction by Oxytocin

What Was Tested

This registered not phased trial tested Oxytocin.

It had two arms (groups): Misoprostol (experimental) and Oxytocin (experimental).

Rectal misoprostol.

Intravenous oxytocin.

The registry classes the interventions as drug.

More on the Plan

The medications will be given just after cord clamping and before delivery of the placenta.

Active management of the third stage of labor will be carried out simultaneously with early cord clamping, gentle downward traction of the placenta to hasten its delivery, and uterine massage in addition to the uterotonic according to assignment of the patient.

Assessment of the uterine condition will be done by the obstetrician or his assistant, together with visually estimating the amount of blood loss.

Failure to achieve adequate uterine contraction and to control post partum hemorrhage (PPH) by the routine uterine massage will urge the use of either different uterotonics or surgical intervention if necessary.

Who Took Part

300 actual participants took part.

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

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

Examples of who could join: Women with single viable pregnancy,. At full term. Whom labor was induced by Oxytocin were eligible.

The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: delivery by cesarean section; received other prophylactic uterotonics.

How the Study Was Run

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

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

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 2016-11 with completion listed for 2017-12-30.

It ran at 1 site in Lebanon.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Hemoglobin level (time frame: 12 to 24 hours post partum).

It also tracked 4 secondary outcomes, for example mean hemoglobin drop, mean estimated blood loss, drop in hemoglobin and side effect of medication.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 300 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.