← Back to Search

Oxytocic

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

Must not have

Inability to give informed consent in the patient's native language

Known bleeding disorder such as von Willebrand's disease or hemophilia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 72 hours

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot understand or sign the consent form in my native language.

Select...

I have a bleeding disorder like von Willebrand's or hemophilia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 hours for immediate postpartum hemorrhage

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 hours for immediate postpartum hemorrhage

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 hours for immediate postpartum hemorrhage for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Endpoint: Time from initial medication administration to vaginal delivery

Secondary study objectives

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

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 4Eligibility criteria met