Comparison of Misoprostol Ripening Efficacy With Dilapan

Induced; Birth Clinical Trial

— COMRED  

Official title:

Dilapan vs Misoprostol for Cervical Ripening [COMRED - Comparison of Misoprostol Ripening Efficacy With Dilapan]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03670836
• Other study ID #: AAAR8566
• Status: Completed
• Phase: Phase 4
• Start date: November 15, 2018
• Est. completion date: July 21, 2021

Study information

• Verified date: May 2022
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: July 21, 2021
• Est. primary completion date: July 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Induced; Birth
• Labor Onset and Length Abnormalities

Intervention

Device:
• Dilapan
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.

Drug:
• Misoprostol
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.

Locations

Country	Name	City	State
United States	University of Texas	Galveston	Texas
United States	New York Presbyterian - Allen Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Medicem International CR s.r.o.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of women achieving vaginal delivery	This is to measure the efficacy of either Dilapan or Misoprostol for cervical ripening	Up to 36 hours after intervention
Secondary	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.	At 12 hours after intervention
Secondary	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	Up to 24 hours after intervention
Secondary	Overall vaginal delivery rate	This is to measure the efficacy of either Dilapan or Misoprostol for cervical ripening	Approximately up to 48 hours
Secondary	Rate of cesarean deliveries	This is to measure the efficacy of either Dilapan or Misoprostol for cervical ripening	Approximately up to 48 hours
Secondary	Total length of hospital stay	This is to measure the cost-effectiveness of either Dilapan or Misoprostol for cervical ripening. Length will be measured in number of days from hospital admission until discharge.	Up to 4 days
Secondary	Percentage of women who developed chorioamnionitis	This is to measure the safety of either Dilapan or Misoprostol for cervical ripening	From delivery until two weeks after discharge (approximately up to 3 weeks)
Secondary	Percentage of women who developed endometritis within 14 days of intervention	This is to measure the safety of either Dilapan or Misoprostol for cervical ripening	From delivery until two weeks after discharge (approximately up to 3 weeks)
Secondary	Percentage of women who developed postpartum hemorrhage	This is to measure the safety of either Dilapan or Misoprostol for cervical ripening, postpartum hemorrhage is defined as estimated blood loss (EBL) > 1000cc and/or drop in Hematocrit (HCT) by 10 points.	From delivery until two weeks after discharge (approximately up to 3 weeks)
Secondary	Percentage of newborns with Apgar score <7 at 5 min	This is to measure the safety of either Dilapan or Misoprostol for cervical ripening by studying the effect on newborns	From birth until two weeks after birth
Secondary	Percentage of newborns with cord arterial blood potential hydrogen (pH) < 7	This is to measure the safety of either Dilapan or Misoprostol for cervical ripening by studying the effect on newborns	From birth until two weeks after birth
Secondary	Percentage of newborns with neonatal intensive care unit (NICU) admission within 14 days after study intervention	This is to measure the safety of either Dilapan or Misoprostol for cervical ripening by studying the effect on newborns	From birth until two weeks after birth
Secondary	Percentage of newborns with antibiotic use within 14 days after study intervention	This is to measure the safety of either Dilapan or Misoprostol for cervical ripening by studying the effect on newborns	From birth until two weeks after birth