PROMMO Trial: Oral Misoprostol vs IV Oxytocin

Early Phase 1

Completed

• Conditions: Premature Rupture of Membrane; Induction of Labor Affected Fetus / Newborn
• Interventions: Drug: Misoprostol Oral Product; Drug: Intravenous Oxytocin

• Registration Number: NCT04478942
• Lead Sponsor: University of Wisconsin, Madison

Brief 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.

Study Timeline

• Study First Submitted: 2020-07-15
• Study First Submitted QC: 2020-07-15
• Study First Posted: 2020-07-21
• Study Start: 2020-10-26
• Primary Completion: 2025-01-14
• Study Completion: 2025-01-14
• Status Verified: 2025-02
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 138

Inclusion Criteria

• 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
• Singleton gestation
• Appropriate gestational age dating by certain LMP or ultrasound performed prior to 20 weeks gestational age

Exclusion Criteria

• Concern for intra-amniotic infection
• Previous Cesarean delivery
• Lack of appropriate dating criteria for the pregnancy
• Inability to give informed consent in the patient's native language
• Known bleeding disorder such as von Willebrand's disease or hemophilia
• Anticoagulation administration within 24 hours of delivery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral misoprostol	Misoprostol Oral Product	At time of delivery, participants randomly assigned to either oral misoprostol will receive 50 mcg of Misoprostol every 4 hours up to 6 doses, OR until simplified Bishop score \>6 (whichever is achieved first).
intravenous oxytocin	Intravenous Oxytocin	At time of delivery, participants randomly assigned to intravenous oxytocin, will be administered the drug per standard of labor and delivery titrations.

Primary Outcome Measures

Name	Time	Method
Primary Endpoint: Time from initial medication administration to vaginal delivery	Up to 72 hours	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

Secondary Outcome Measures

Name	Time	Method
Secondary endpoint 2: Rate of Suspected or Confirmed Intrapartum Intramniotic Infection	Prior to delivery	Rates of infectious morbidity in peripartum women and neonates exposed to misoprostol versus oxytocin in prelabor rupture of membranes.
Secondary endpoint 3: Rate of Suspected Endometritis	From delivery to 6 weeks postpartum	patient satisfaction surveys
Secondary endpoint 1: Rate of Postpartum Hemorrhage	up to 24 hours for immediate postpartum hemorrhage	the rate of postpartum hemorrhage in women with prelabor rupture of membranes with use of oral misoprostol for cervical ripening
Secondary endpoint 4: Rate of Infectious Morbidity for Neonates	up to 6 weeks of life	Neonatal infection that is diagnosed within the first 6 weeks of life related to maternal infection diagnosed by positive blood cultures or fever.
Secondary endpoint 5: Participant Satisfaction as Measured by modified Labour Agentry Scale	Postpartum day one with repeat instrument at 6 weeks postpartum	The modified labour agentry scale has scores that indicate satisfaction with the patient's experience in labor

Trial Locations

Locations (1)

UnityPoint Health- Meriter Hospital; 🇺🇸 Madison, Wisconsin, United States