Comparison of Misoprostol Ripening Efficacy With Dilapan

Columbia University307 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

307

Conditions

Labor Onset and Length Abnormalities Induced; Birth

Interventions

DilapanDEVICE

Dilapan-S® is a mechanical method for cervical ripening using rods made of a patented hydrogel Aquacryl, it is marketed in form of rods of 3 and 4 mm diameter. It is FDA approved for cervical ripening.

MisoprostolDRUG

25mcg of Misoprostol will be administered orally every 2 hours (maximum of 6 doses) Misoprostol is a prostaglandin E1 analog approved for treatment and prevention of gastric ulcers. The use of Misoprostol appears to be safe and effective for induction of labor when used in low dose.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

New York Presbyterian - Allen Hospital

New York, New York, United States

University of Texas

Galveston, Texas, United States

Outcomes

Primary Outcomes

Number of Women Achieving Vaginal Delivery Within 36 Hours After Initiation of Cervical Ripening in ITT Population

This is to measure the efficacy of either Dilapan or Misoprostol for cervical ripening. Intent-to-treat Population (ITT) includes all patients that were randomized into the study. ITT participants will be analyzed in accordance with their randomized study treatment (i.e. in the treatment group they were originally allocated, regardless of treatment actually received). ITT will be used for evaluation of the baseline characteristics and as the primary population for efficacy assessments.

Time frame: Up to 36 hours after intervention

Number of Women Achieving Vaginal Delivery Within 36 Hours After Initiation of Cervical Ripening in PP Population

This is to measure the efficacy of either Dilapan or Misoprostol for cervical ripening.

Time frame: Up to 36 hours after intervention

Secondary Outcomes

Change in Bishop Score

The Bishop Score (also known as Pelvic Score) is the most commonly used method to rate the readiness of the cervix for induction of labor. The Bishop Score gives points to 5 measurements of the pelvic examination dilation, effacement of the cervix, station of the fetus, consistency of the cervix, and position of the cervix. It ranges from 0 to 13. Higher score is associated with increased likelihood of vaginal delivery.

Time frame: Baseline and 12 hours after intervention

Percentage of Women Delivering Vaginally in 24 Hours After the Initiation of Intervention

This is to measure the efficacy of either Dilapan or Misoprostol for cervical ripening

Time frame: Up to 24 hours after intervention

Overall Vaginal Delivery Rate

This is to measure the efficacy of either Dilapan or Misoprostol for cervical ripening

Data from ClinicalTrials.gov

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