CompletedEarly Phase 1

PROMMO Trial: Oral Misoprostol vs IV Oxytocin

United States138 participantsStarted 2020-10-26

Plain-language summary

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 can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary Endpoint: Time from initial medication administration to vaginal delivery

Timeframe: Up to 72 hours

Trial details

NCT IDNCT04478942

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-14

View on ClinicalTrials.gov More Premature Rupture of Membrane trials