138 Participants Needed

Misoprostol vs Oxytocin for Induction of Labor

(PROMMO Trial)

SE
JA
Overseen ByJacquelyn Adams, MD
Age: 18+
Sex: Female
Trial Phase: Phase < 1
Sponsor: University of Wisconsin, Madison
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

JA

Jacquelyn Adams, MD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

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).
See 4 more

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.
See 3 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: intravenous oxytocinActive Control1 Intervention
Group II: oral misoprostolActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+
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