Oxytocin/Foley vs. Oxytocin for Induction in Patients With PPROM

What Was Tested

This registered phase 4 trial tested Oxytocin.

Data on the optimal mode of labor induction after preterm prelabor rupture of membranes (PPROM) is lacking.

It had two arms (groups): Oxytocin plus Foley (experimental) and Oxytocin Only (active comparator).

• Induction of labor with intravenous oxytocin and a transcervical Foley catheter.

• Induction of labor with intravenous oxytocin.

The registry classes the interventions as combination product and drug.

Who Took Part

Enrollment: 80 planned participants were the target.

It was open to women only aged from 18 years up to 50 years.

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

Examples of who could join: Patients 18-50 years of age;. The patient is fluent in English, physically and mentally able to understand the informed consent, and is willing to participate in this study;. Cervical dilation \</= 2cm. Fetal cephalic presentation;.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: spontaneous labor; known allergy to latex;; cervical dilation \>2cm;.

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.

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 2025-07-14 with completion listed for 2026-07-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Vaginal Delivery within 12 Hours (time frame: 12 hours).

It also tracked 19 secondary outcomes, for example Vaginal Delivery Rate, Intraamniotic Infection, Operative vaginal delivery, Cesarean delivery, Estimated and quantitative blood loss and Blood transfusion.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 80 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.