PROMMO Trial: Oral Misoprostol vs IV Oxytocin

What Was Tested

The trial (early phase 1) is built around Oxytocin.

This is a prospective, randomized trial looking at the ideal method of labor induction for women with prelabor rupture of membranes and an unfavorable cervical Bishop score.

The study will compare oral misoprostol and intravenous oxytocin.

It had two arms (groups): oral misoprostol (active comparator) and intravenous oxytocin (active comparator).

At time of delivery, participants randomly assigned to intravenous oxytocin, will be administered the drug per standard of labor and delivery titrations.

The registry classes the interventions as drug.

More on the Plan

The purpose of this study is to look at optimal induction management of prelabor rupture of membranes (PROM) at or beyond 34 weeks gestational age.

Sub objective 2: To evaluate the rates of infectious morbidity in peripartum women and neonates exposed to misoprostol versus oxytocin in PROM.

Hypothesis: The use of oral misoprostol will result in lower rates of infectious morbidity in mother and neonate.

Sub objective 3: To analyze patient satisfaction surveys.

Who Took Part

138 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: Early Term to late term pregnancy (\>37 weeks and 0 days and \<42 weeks and 0 days). Late Preterm Pregnancy (34 weeks and 0 days and \<37 weeks). Confirmed rupture of membranes by either sterile speculum exam or AmniSure. Simplified Bishop Score ≤ 6. Maternal Age \> 18 years old.

The full record lists 7 inclusion and 6 exclusion criteria; among the exclusions: concern for intra-amniotic infection; previous cesarean delivery; lack of appropriate dating criteria for the pregnancy.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2020-10-26 with completion listed for 2025-01-14.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Primary Endpoint: Time from initial medication administration to vaginal delivery (time frame: Up to 72 hours).

It also tracked 5 secondary outcomes, for example Secondary endpoint 1: Rate of Postpartum Hemorrhage, Secondary endpoint 2: Rate of Suspected or Confirmed Intrapartum Intramniotic Infection, Secondary endpoint 3: Rate of Suspected Endometritis, Secondary endpoint 4: Rate of Infectious Morbidity for Neonates and Secondary endpoint 5: Participant Satisfaction as Measured by modified Labour Agentry Scale.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Oxytocin in 138 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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