PROMMO Trial: Oral Misoprostol vs IV Oxytocin (NCT04478942) | Clinical Trial Compass
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.
1This trial compared oral misoprostol to IV oxytocin for inducing labor after premature rupture of membranes — based on its findings, which of those two approaches would you recommend for my situation and why?
2Since this was an early Phase 1 trial, what does that mean for how confident we can be in the safety and effectiveness of oral misoprostol compared to IV oxytocin for my specific case?
3The trial measured how long it took from the first dose of medication to vaginal delivery — did one method show a meaningfully faster or slower time to delivery, and does that matter for my baby's health given my premature rupture of membranes?
4Now that this trial is completed, has the data influenced how you currently approach induction of labor with ruptured membranes, or is IV oxytocin still your standard practice?
5Are there any risks or concerns specific to oral misoprostol for someone in my situation — such as how far along I am or other health factors — that would make one method safer than the other for me and my baby?
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
1
Primary Endpoint: Time from initial medication administration to vaginal delivery