NCT04478942

PROMMO Trial: Oral Misoprostol vs IV Oxytocin

PROMMO Trial: Prelabor Rupture of Membranes Managed With Oral Misoprostol Versus Intravenous Oxytocin

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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. Objective 1: To determine if there is a decrease in time from initiation of induction of labor to vaginal delivery in women with an unfavorable cervix with the use of oral misoprostol versus intravenous oxytocin. Hypothesis: Cervical ripening with misoprostol will be beneficial in women with an unfavorable cervix. Sub objective 1: To determine if the use of oral misoprostol for cervical ripening decreases the rate of postpartum hemorrhage in women with PROM. Hypothesis: Misoprostol use will result in significantly lower rate of postpartum hemorrhage. 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. Hypothesis: Patients in the oral misoprostol group will be more satisfied with their labor experience. Exploratory Outcome To determine if there is a difference in cost between induction of labor in women with an unfavorable cervix with the use of oral misoprostol versus intravenous oxytocin. Hypothesis: The use of oral misoprostol will be cost effective in women presenting with PROM and an unfavorable cervix.

Conditions

• Premature Rupture of Membrane
• Induction of Labor Affected Fetus / Newborn

Interventions

Type	Name	Description
DRUG	Misoprostol Oral Product	Misoprostol will be dosed using the preexisting UnityPoint Health-Meriter Protocol for oral misoprostol administration.
DRUG	Intravenous Oxytocin	Intravenous oxytocin administration will also follow standard, UnityPoint Health-Meriter Protocol.

Timeline

• Start date: 2020-10-26
• Primary completion: 2025-01-14
• Completion: 2025-01-14
• First posted: 2020-07-21
• Last updated: 2025-08-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study