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NCT Number: NCT04478942

PROMMO Trial: Oral Misoprostol vs IV 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.

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Key information

Conditions

Premature Rupture of Membrane Female Urogenital Diseases and Pregnancy Complications Fetal Membranes, Premature Rupture Induction of Labor Affected Fetus / Newborn Obstetric Labor Complications Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

UnityPoint Health- Meriter Hospital

Madison, Wisconsin, 53705-2216, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol Oral Product

Drug

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

Other names: Oral Product

Intravenous Oxytocin

Drug

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

Other names: IV Product

Primary outcomes

  1. Primary Endpoint: Time from initial medication administration to vaginal delivery

    Time frame: 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 outcomes

  1. Secondary endpoint 1: Rate of Postpartum Hemorrhage

    Time frame: 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

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

    Time frame: Prior to delivery

    Rates of infectious morbidity in peripartum women and neonates exposed to misoprostol versus oxytocin in prelabor rupture of membranes.

  3. Secondary endpoint 3: Rate of Suspected Endometritis

    Time frame: From delivery to 6 weeks postpartum

    patient satisfaction surveys

  4. Secondary endpoint 4: Rate of Infectious Morbidity for Neonates

    Time frame: 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.

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Acronym: PROMMO

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jul 21, 2020
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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