Balloon + Oxytocin Versus Oral Misoprostol to Induce Labor in Case of PROM (RUBAPRO2)

What Was Tested

The trial (phase 4) is built around Oxytocin.

It had two arms (groups): Balloon+oxytocin (experimental) and Oral misoprostol (active comparator).

Mecanical cervical ripening will be done by transcervical balloon (Teleflex French Dufour catheter CH20 reference 174000). Oxytocin will be started 6 hours after balloon insertion. At H12 balloon will be removed and induction continued by oxytocin alone.

The registry classes the interventions as device and drug.

More on the Plan

Recently, a comparison 1 to 1 between these two methods was conducted in singletons with comparable results.

Patient satisfaction concerning experience of IOL will be assessed using a validated survey- the EXperience of Induction Tool (EXIT) - translated in French language (Beckman et al., 2017).

Study type: Multi-center, randomized, controlled, open-label therapeutic trial with two parallel arms.

Number of centers: 5 Study Description: The study group is the balloon catheter group with addition of oxytocin as early as 6h after the catheter insertion.

Who Took Part

Enrollment: 152 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age \> 18 years old,. Pregnant, Gestational age ≥ 37 weeks. Singleton pregnancy with cephalic presentation. PROM without labour beyond 12 hours. Unfavourable cervix (Bischop score \< 6).

The full record lists 9 inclusion and 30 exclusion criteria; among the exclusions: unable to understand french language; contraindication for vaginal delivery; loss of meconium amniotic fluid (la).

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.

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

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

It started in 2023-01-18 with completion listed for 2025-08-29.

It ran at 5 sites in France (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Vaginal delivery <24hours (time frame: at birth). Patient satisfaction (time frame: up to 4 days).

It also tracked 19 secondary outcomes, for example Duration from rupture to beginning of induction, Duration between IOL and delivery, Duration of balloon exposure or misoprostol exposure, Misoprostol received, Bishop score on balloon removal and Balloon in place (yes/no).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 152 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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