Pitocin or Oral Misoprostol for PROM IOL

What Was Tested

In this phase 4 trial, researchers set out to test Oxytocin.

Premature rupture of membranes (PROM) is a common occurrence of pregnancies at term.

The ideal agent for IOL is not known, particularly among specific subpopulations.

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

The registry classes the interventions as drug.

More on the Plan

For this reason, the American College of Obstetricians and Gynecologists (ACOG) endorses induction of labor for PROM "if spontaneous labor does not occur near the time of presentation." The optimal method for PROM induction is less clear.

Prior literature has examined the use of Pitocin (Oxytocin), vaginal and oral misoprostol, and dinoprost with mixed results.

Utilizing oral misoprostol would eliminate the need for a vaginal exam for administration, thereby potentially mitigating this risk of infection.

Currently, vaginal and oral misoprostol as well as oxytocin are used routinely in clinical care based on provider discretion.

Who Took Part

Enrollment: 108 actual participants took part.

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

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

Examples of who could join: PROM \</= 24 hours with no evidence of labor. \>/= 36 weeks gestation. Agreeable to induction of labor. Cervical dilation \</=2 cm AND Bishop score \< 8.

The full record lists 8 inclusion and 6 exclusion criteria; among the exclusions: prior cesarean section; other contraindication to vaginal delivery; intrauterine fetal demise.

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.

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

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

It started in 2019-08-12 with completion listed for 2022-12-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Time From Induction of Labor (IOL) to Delivery.

It also tracked 7 secondary outcomes, for example Infection, Time From Premature Rupture of Membranes (PROM) to Delivery, Time From IOL to Vaginal Delivery, Time From PROM to Vaginal Delivery, Cesarean Delivery and Maternal Morbidity.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 108 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.