New York, New York 10034


Purpose:

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.


Study summary:

In developed nations 25 % of pregnant women undergo labor induction for various indications. Likelihood of vaginal delivery depends on the degree of ripeness of cervix. Majority of women undergoing induction of labor are candidates for cervical ripening. Dilapan is an osmotic hygroscopic dilator of cervix commonly used for cervical preparation for mid trimester abortions. It has been proven safe for use for induction of Labor (IOL) at term. Misoprostol is a synthetic prostaglandin E1 analogue, widely used for cervical ripening and IOL in United States and is considered as standard of care. This is a non-inferiority, unblinded randomized, controlled trial where 322 eligible participants undergoing IOL at >37 weeks gestation and admitted to labor and delivery unit will be enrolled and randomly assigned in a ratio 1:1 to either receive Dilapan or Misoprostol for cervical ripening. After randomization all participants will undergo assessment as per standard of care. Participants will have either 1-5 Dilapan rods inserted into their cervix by the providers or receive 25 mcg of misoprostol orally every 2 hours to a maximum of 6 doses over 12 hours. Participants will be evaluated for artificial rupture of membranes and initiation of oxytocin for inducing uterine contraction. A diagnosis of failed IOL will be made if patient does not go into active labor within 24 hours after initiation of Oxytocin and Artificial Rupture Of Membranes (AROM). Intrapartum management will be according to institutional guidelines. All participants will be followed up and contacted by phone 2 weeks after discharge regarding their experience with the method of induction.


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


NCT ID:

NCT03670836


Primary Contact:

Principal Investigator
Rachana Gavara, MD
rg2460@cumc.columbia.edu

Rachana Gavara, MD
Phone: 212-304-6929
Email: rg2460@cumc.columbia.edu


Backup Contact:

Email: ba2532@cumc.columbia.edu
Barouyr Ajemian, MD
Phone: 646-891-7934


Location Contact:

New York, New York 10034
United States

Barouyr Ajemian, MD
Phone: 646-891-7934
Email: ba2532@cumc.columbia.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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