Management of Prelabor Rupture of the Membranes at Term

What Was Tested

This registered not phased trial tested Oxytocin for endometriosis.

It had two arms (groups): Immediate oxytocin infusion (experimental) and Expectant management for 24 hours (experimental).

Once the patient will arrive at the maternity ward with prelabor rupture of membranes, she will receive oxytocin for augmentation of labor.

Once the patient will arrive at the maternity ward with prelabor rupture of membranes, the researchers will wait for spontaneous delivery to occur. After 24 hours of rupture of membranes, the woman will receive oxytocin for augmentation of labor.

The registry classes the interventions as drug.

More on the Plan

Prelabor rupture of the membranes (PROM) refers to rupture of the fetal membranes prior to the onset of regular uterine contractions.

PROM at term can be managed actively by induction of labor or expectantly by waiting for the onset of a spontaneous labor.

Others disagree with those associations.

Who Took Part

524 planned participants were the target.

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: Primiparous women with a singleton pregnancy that are admitted with prelabor rupture of membranes. Women at gestational age 370/7 or more.

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: age 18 and under; high order gestation; women with contraindication for a vaginal delivery.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

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

Nothing was hidden in this open-label Oxytocin study: the endometriosis participants and staff both knew the treatment.

It started in 2020-05-01 with completion listed for 2024-05-01.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Maternal infectious morbidity (time frame: Up to 48 hours postpartum).

It also tracked 3 secondary outcomes, for example Length of latent and active phases of labor, Adverse maternal outcome and Adverse neonatal outcome.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 524 people with endometriosis.

With 524 participants it is a large trial for this field.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, Endometriosis research.