Comparison of Misoprostol Ripening Efficacy With Dilapan

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.

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