Balloon plus oxytocin or oral misoprostol for labour induction in prelabour rupture of membranes (PROM): protocol for a randomised controlled trial (RUBAPRO2)

What Was Tested

The paper reports a study of Oxytocin, published as a clinical study.

The optimal strategy for induction of labour (IOL) in cases of prelabour rupture of membranes (PROM) with an unfavourable cervix is elusive.

The RUBAPRO2 trial was approved by the French national agency for drug safety and committee for protection of persons involved in biomedical research on 15 September 2022.

Who Took Part

The study group was 520 women.

The age groups tagged for this paper are adults, women only.

A total of 520 women will be recruited in five university hospitals in France and randomised at a 1:1 ratio with stratification by study centre.Main inclusion criteria are nulliparous women with gestational age ≥37 weeks, PROM without labour beyond 12 hours, unfavourable cervix (Bishop score <6), and singleton pregnancy with cephalic presentation.

Three dimensions are explored on the EXIT scale: time taken to give birth, discomfort with IOL and experience of subsequent contractions.

How the Study Was Run

The researchers set it up as a randomized, open-label, multicenter and parallel-group study.

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

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

More than one site took part, so the women came from several places.

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

If the balloon is expelled earlier than 6 hours after insertion and the cervix is still unfavourable, another balloon is placed.

What Was Measured

The subject headings attached to it are Misoprostol, Oxytocin, Labor, Induced, Oxytocics, Premature Rupture of Fetal Membranes, Randomized Controlled Trials as Topic and Patient Satisfaction.

The authors tagged it with the keywords OBSTETRICS and Pregnant Women.

What This Means in Plain Language

The paper is a randomized, open-label and multicenter study of Oxytocin in 520 women.

With several hundred people or more, it is a fairly large study for this kind of research.

The publication is from 2026 (BMJ open), a journal based in England.

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