PROMMO Trial: Oral Misoprostol vs IV Oxytocin

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Wisconsin, Madison
• Treatments: Misoprostol; Oxytocin

Criteria

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