Premature Rupture of Mambrane and Unfavourable Cervix

What Was Tested

In this not phased trial, researchers set out to test Oxytocin.

The paucity of published data concerning the issue of mechanical labor induction in the setting of Term PROM has led them to undertake the present clinical trial.

It had two arms (groups): GROUP 1: Oxytocin infusion alone (experimental) and double balloonand oxytocin (experimental).

GROUP 1: Oxytocin infusion alone.

Insertion of the double balloon and oxytocin.

The registry classes the interventions as device, drug, other and procedure.

More on the Plan

This will be a prospective randomised trial.

Two hundred pregnant women with term PROM and an unfavourable cervix (Bishop Score ≤ 4) are expected to be entered into the study (see statistical analysis below).

All eligible women will be presented with the study protocol by a study coordinator.

Women interested in participating will read and sign the informed consent.

Who Took Part

300 planned participants were the target.

It was open to women only aged from 16 years up to 50 years.

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

Examples of who could join: Diagnosed to be pregnant with PROM at \> 34 week. Found to have a Bishop score of 4 points or less. Diagnosed as having a singleto. Willingness to comply with the protocol for the duration of the study. Have signed an informed consent.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: any contraindication for a vaginal deliver; regular uterine contractn; evidence of chorio-amonitis.

How the Study Was Run

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

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

It started in 2012-07 with completion listed for 2014-07.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): PPROM/PROM to delivery interval (time frame: 3year).

What This Means in Plain Language

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