Premature Rupture of Membranes With a Bishop Score<6: Comparison of Medical Induction/Expectant Management

What Was Tested

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

The study is intended to compare expectant management and on presentation labor induction in women with premature rupture of membranes.

The means of labor induction and cervical ripening are either oxytocin or dinoprostone.

Expectant management in this obstetrical state means waiting 24 hours from the onset of rupture of membranes and then commencing labor induction with either oxytocin or dinoprostone depending on the patient's obstetrical history and cervical condition.

It had four arms (groups): Expectant Management-Dinoprostone (active comparator), Expectant Management-Oxytocin (active comparator), Active Management-Dinoprostone (experimental) and Active Management-Oxytocin (experimental).

Women with premature rupture of membranes who are not in active labor and have an unfavorable cervix (Bishop score\<6). Labor induction will be initiated with Dinoprostone after 24 hours of waiting depending on obstetric history and cervical conditions.

Women with premature rupture of membranes who are not in active labor and have an unfavorable cervix (Bishop score\<6). Labor induction will be initiated with oxytocin after 24 hours of waiting depending on obstetric history and cervical conditions.

Women with premature rupture of membranes who are not in active labor and have an unfavorable cervix (Bishop score\<6). Labor induction will be initiated with Dinoprostone on presentation depending on obstetric history and cervical conditions.

The registry classes the interventions as drug.

More on the Plan

In the setting of premature rupture of membranes in term pregnancies, it is customary in women who are not in active labor to wait for 24 hours before attempting to induce labor.

The means of labor induction used at their medical center are either intravenous oxytocin or per-vaginal dinoprostone, depending on patient's obstetric history and cervical conditions.

The participants will be followed from the time of presentation with rupture of membranes at the delivery room and until the time of delivery.

Further obstetric, clinical and demographic information will be acquired from the patient's electronic medical file for analysis accuracy and sub-analysis.

Who Took Part

458 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: Term pregnancies \>37 weeks of gestation. Certain rupture of membranes. Bishop score \< 6. No obstetric or clinical contraindications for labor induction. Reactive non stress test on presentation.

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: previous cesarean section; previous uterine surgeries (myomectomy etc.); placenta previa.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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

Being open-label, the Oxytocin study did not mask who received what.

It started in 2016-08-01 with completion listed for 2021-11-01.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Vaginal delivery rate (time frame: Up to 7 days from the time of presentation with rupture of membranes).

It also tracked 2 secondary outcomes, for example Interval to delivery and Caesarian delivery rate.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 458 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.