Comparison of Misoprostol Ripening Efficacy With Dilapan

• Status: Completed
• Trial end date: 2021-02-22
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to find out if Dilapan works as well as Misoprostol for preparing the mouth of the uterus (cervix) for inducing labor in women who need to undergo this procedure. The primary objective is to assess the efficacy of Dilapan for cervical ripening compared to Misoprostol in women undergoing Induction of labor (IOL) at or more than 37 weeks gestation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Columbia University
• Collaborator: Medicem International CR s.r.o.
• Treatments: Misoprostol

Criteria

Inclusion Criteria:

1. Women undergoing labor induction with a gestation of ≥37 weeks (based on a sure last menstrual period and an ultrasound done before 22 0/7 weeks)

2. Live fetus with in cephalic presentation

3. Singleton pregnancy

4. Able to provide informed consent for participation in the study

Exclusion Criteria:

1. Contraindication for vaginal delivery

2. Age less than 18 years

3. Prior uterine scar from a cesarean section or myomectomy

4. Patients who have HELLP syndrome or eclampsia

5. Active genital herpes at the time of labor induction

6. Complex medical problems that may require assistance with second stage of labor

7. Bishop score ≥ 6

8. Major fetal congenital anomalies (as assessed by investigator)

9. Premature rupture of membranes