Misoprostol vs Oxytocin for Induction of Labor

(PROMMO Trial)

Overseen By Jacquelyn Adams, MD

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: University of Wisconsin, Madison

Must not be taking: Anticoagulants

Disqualifiers: Intra-amniotic infection, Previous cesarean, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: Up to 72 hours

138 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jacquelyn Adams, MD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

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.

Inclusion Criteria

Early Term to late term pregnancy (>37 weeks and 0 days and <42 weeks and 0 days)

Confirmed rupture of membranes by either sterile speculum exam or AmniSure

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

Exclusion Criteria

The pregnancy cannot be accurately dated.

There is a worry about an infection inside the womb.

I received blood thinners within a day after giving birth.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either oral misoprostol or intravenous oxytocin for labor induction

Up to 72 hours

In-hospital stay for labor and delivery

Immediate Postpartum

Monitoring for postpartum hemorrhage and initial maternal and neonatal health assessments

Up to 24 hours

Follow-up

Participants are monitored for safety, effectiveness, and satisfaction after delivery

6 weeks

Postpartum day one visit, follow-up at 6 weeks postpartum

Treatment Details

Interventions

• Intravenous Oxytocin
• Misoprostol Oral Product

Trial Overview 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.

Participant Groups

Group I: intravenous oxytocin Active Control 1 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 misoprostol Active Control 1 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).

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+