NCT03670836

Comparison of Misoprostol Ripening Efficacy With Dilapan

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 307 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Labor Onset and Length Abnormalities
• Induced; Birth

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-11-15
• Primary completion: 2021-07-21
• Completion: 2021-07-21
• First posted: 2018-09-14
• Last updated: 2024-07-19
• Results posted: 2024-07-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study