PGE2 Followed by Oxytocin vs Oxytocin in Term PROM (POXY-PROM)

What Was Tested

The trial (not phased) is built around Oxytocin.

This study is being done to learn more about the best way to start labor for pregnant women whose water breaks at term before labor begins, a condition called term prelabor rupture of membranes (term PROM).

When this happens and the cervix is not ready for labor, it is unclear which induction method works best and is safest for mother and baby.

The purpose of this study is to compare two common ways to induce labor in women with term PROM and an unfavorable cervix (Bishop score ≤ 6).

It had two arms (groups): Dinoprostone (Propess) + Oxytocin (experimental) and Immediate Oxytocin Induction (active comparator).

The registry classes the interventions as drug.

More on the Plan

Additional high-quality randomized evidence is therefore required to guide clinical practice in this population.

This randomized controlled trial compares two induction strategies for women with term PROM and an unfavorable cervix: (1) cervical ripening using a 6-hour vaginal dinoprostone (Propess) insert followed by intravenous oxytocin if labor has not commenced, and (2) immediate induction with intravenous oxytocin alone.

Participants are randomly assigned in a 1:1 ratio using a computer-generated randomization sequence with variable block sizes of 4 and 6, with allocation concealment ensured through centralized randomization.

Randomization is performed after confirmation of eligibility and completion of the informed consent process.

Who Took Part

The registry lists 450 planned participants were the target.

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: Maternal age ≥ 18 years. Gestational age from 37 to 42 weeks, determined by last menstrual period or by a first- or second-trimester ultrasound. Live singleton fetus. Prelabor rupture of membranes (PROM) confirmed by at least one of the following:. Amniotic fluid visibly draining from the cervical os during sterile speculum examination.

The full record lists 10 inclusion and 6 exclusion criteria; among the exclusions: active labor; previous uterine surgery (e.g., cesarean section); chorioamnionitis or non-reassuring fetal status.

How the Study Was Run

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

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.

Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2026-02-10 with completion listed for 2027-12.

It ran at 1 site in Vietnam.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Vaginal delivery (time frame: From induction until delivery, assessed up to 36 hours after randomization).

It also tracked 24 secondary outcomes, for example Mode of delivery, Time from induction of labor to delivery, Oxytocin augmentation, Uterine hyperstimulation, Maternal satisfaction and Haemorrhage.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 450 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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