Misoprostol vs Oxytocin for Induction of Labor (PROMMO Trial)

Phase < 1

Recruiting

Led By Jacquelyn Adams, MD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Late Preterm Pregnancy (34 weeks and 0 days and <37 weeks)

Maternal Age > 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 72 hours

Awards & highlights

PROMMO Trial Summary

This trial is comparing two methods of labor induction for women with prelabor rupture of membranes and an unfavorable cervical Bishop score.

Who is the study for?

The PROMMO Trial is for pregnant women over 18 with a single baby, between 34 and less than 42 weeks along, who have had their water break before labor starts and an unfavorable cervix for delivery. Women must not have had a previous C-section, bleeding disorders like von Willebrand's or hemophilia, recent anticoagulants use, or infection concerns.Check my eligibility

What is being tested?

This study compares two ways to start labor when the water breaks early: swallowing Misoprostol pills versus getting Oxytocin through an IV. It aims to find out which method works best for women with a low Bishop score indicating the cervix isn't ready for birth.See study design

What are the potential side effects?

Misoprostol may cause stomach pain, nausea, diarrhea, headache or fever. Oxytocin can lead to rapid contractions that might stress the baby or cause discomfort in the mother; it could also result in low blood pressure.

PROMMO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am in my late preterm pregnancy stage (34-36 weeks).

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I am over 18 years old.

PROMMO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ prior to delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~prior to delivery

This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to delivery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Endpoint: Time from initial medication administration to vaginal delivery

Secondary outcome measures

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

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PROMMO Trial Design

2Treatment groups

Active Control

Group I: intravenous oxytocinActive Control1 Intervention

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

Group II: oral misoprostolActive Control1 Intervention

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).

0 / 2Eligibility criteria met