Comparison of Misoprostol Ripening Efficacy With Dilapan

Completed · Phase 4

Conditions studied: Labor Onset and Length Abnormalities, Induced; Birth

In brief

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.

Key facts

Study ID

NCT03670836

Run by

Columbia University

People needed

307

Starts

2018-11-15

Expected to finish

2021-07-21

Last updated by the study team

2024-07-19

Who can join

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

You may qualify if…

• 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)
• Live fetus with in cephalic presentation
• Singleton pregnancy
• Able to provide informed consent for participation in the study

You may not qualify if…

• Contraindication for vaginal delivery
• Age less than 18 years
• Prior uterine scar from a cesarean section or myomectomy
• Patients who have HELLP syndrome or eclampsia
• Active genital herpes at the time of labor induction
• Complex medical problems that may require assistance with second stage of labor
• Bishop score ≥ 6
• Major fetal congenital anomalies (as assessed by investigator)
• Premature rupture of membranes

Where it is running

• New York Presbyterian - Allen Hospital — New York, New York, United States
• University of Texas — Galveston, Texas, 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.