PROMMO Trial: Oral Misoprostol vs IV Oxytocin

NCT04478942 | Completed Early Phase 1 DMC FDA Drug

• 5 other identifiers: 2025-0770A532860SMPH/OBSTET & GYNECOLProtocol Version 9/20/20232020-0240
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint: Time from initial medication administration to vaginal delivery

  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

  Up to 72 hours

Secondary Outcomes (5)

• Secondary endpoint 1: Rate of Postpartum Hemorrhage

  up to 24 hours for immediate postpartum hemorrhage

• Secondary endpoint 2: Rate of Suspected or Confirmed Intrapartum Intramniotic Infection

  Prior to delivery

• Secondary endpoint 3: Rate of Suspected Endometritis

  From delivery to 6 weeks postpartum

• Secondary endpoint 4: Rate of Infectious Morbidity for Neonates

  up to 6 weeks of life

• Secondary endpoint 5: Participant Satisfaction as Measured by modified Labour Agentry Scale

  Postpartum day one with repeat instrument at 6 weeks postpartum

Study Arms (2)

oral misoprostol

ACTIVE COMPARATOR

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).

Drug: Misoprostol Oral Product

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.

Drug: Intravenous Oxytocin

Interventions

Misoprostol Oral Product DRUG

Misoprostol will be dosed using the preexisting UnityPoint Health-Meriter Protocol for oral misoprostol administration.

Also known as: Oral Product

oral misoprostol

Intravenous Oxytocin DRUG

Intravenous oxytocin administration will also follow standard, UnityPoint Health-Meriter Protocol.

Also known as: IV Product

intravenous oxytocin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

UnityPoint Health- Meriter Hospital

Madison, Wisconsin, 53705-2216, United States

Location

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Jacquelyn Adams, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 21, 2020
• Study Start: October 26, 2020
• Primary Completion: January 14, 2025
• Study Completion: January 14, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)