CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 307 enrolled
Drug / intervention
Misoprostol +1 moredrug
Likely dose
Misoprostol 25mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03670836
NCT03670836Phase 4Completed
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Dilapan vs Misoprostol for Cervical Ripening [COMRED - Comparison of Misoprostol Ripening Efficacy With Dilapan]

Columbia University·interventional·Posted Sep 14, 2018·Updated Jul 19, 2024

In Brief

A Phase 4 clinical trial evaluating Dilapan and Misoprostol for Labor Onset and Length Abnormalities and Induced; Birth. Completed, enrolled 307 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLabor Onset and Length Abnormalities, Induced; Birth
CountriesUnited States
CollaboratorsMedicem International CR s.r.o.

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedSep 14, 2018
Enrollment StartNov 15, 2018
Primary CompletionJul 21, 2021
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 7.8 years ago

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.