Cervical Ripening in Premature Rupture of Membranes

What Was Tested

This registered not phased trial tested Oxytocin.

It had two arms (groups): Misoprostol (active comparator) and Oxytocin Alone (active comparator).

Those randomized to the oxytocin arm will receive infusion of oxytocin, which will then be titrated per hospital protocol or until adequate contractions.

The registry classes the interventions as drug.

More on the Plan

The researchers will perform a prospective randomized control trial involving women with singleton gestation at ≥ 34 weeks gestation who require an induction of labor after diagnosis of PROM with an unfavorable cervix.

Cervical status will be assessed by visual exam, digital exam or transvaginal ultrasound to assign a Bishop score (dilation, effacement, station, consistency \& position).

Determination of patient eligibility will be based on the clinical exam and confirmation of PROM.

Upon diagnosis, if the patient meets inclusion criteria and accepts to participate in the study, they will be consented by the study investigator and then be randomized to prostaglandin followed by oxytocin or oxytocin alone group.

Who Took Part

230 actual participants took part.

It was open to women only aged from 15 years up to 50 years.

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

Examples of who could join: All pregnant women diagnosed with PROM without evidence of labor requiring induction. Gestational Age \> 34 weeks. Bishop score \< 6. Category I Fetal heart rate tracing.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: contraindication to induction of labor; multiple gestation; fetal anomalies.

How the Study Was Run

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

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

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

It started in 2014-10-01 with completion listed for 2016-05-30.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Rate of Cesarean Section (time frame: within 48 hours).

It also tracked 1 secondary outcome, for example Maternal and Neonatal Infectious Morbidity.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 230 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Oxytocin compound page, all human trials.