PROMMO Trial: Oral Misoprostol vs IV Oxytocin

Completed · Early Phase 1

Conditions studied: Premature Rupture of Membrane, Induction of Labor Affected Fetus / Newborn

In brief

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.

Key facts

Study ID

NCT04478942

Run by

University of Wisconsin, Madison

People needed

138

Starts

2020-10-26

Expected to finish

2025-01-14

Last updated by the study team

2025-08-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UnityPoint Health- Meriter Hospital — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.