Status:
COMPLETED
PROMMO Trial: Oral Misoprostol vs IV Oxytocin
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Premature Rupture of Membrane
Induction of Labor Affected Fetus / Newborn
Eligibility:
FEMALE
18+ years
Phase:
EARLY_PHASE1
Brief 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 ora...
Detailed Description
The purpose of this study is to look at optimal induction management of prelabor rupture of membranes (PROM) at or beyond 34 weeks gestational age. Objective 1: To determine if there is a decrease in...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 14 2025
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT04478942
Start Date
October 26 2020
End Date
January 14 2025
Last Update
August 28 2025
Active Locations (1)
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1
UnityPoint Health- Meriter Hospital
Madison, Wisconsin, United States, 53705-2216