CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 419 enrolled
Drug / intervention
Dilapan +1 moredevice
Likely dose
Not stated in 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/NCT02899689
NCT02899689N/ACompleted
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Induction of Labor in Women With Unfavorable Cervix: Randomized Control Study Comparing Dilapan to Foley Bulb

The University of Texas Medical Branch, Galveston·interventional·Posted Sep 14, 2016·Updated Nov 18, 2020

In Brief

A clinical study evaluating Dilapan and Foley Catheter for Pre-induction Dilation of Cervix. Completed, enrolled 419 participants across 2 sites.

Detailed Summary

Women undergoing mechanical cervical ripening for labor induction will be randomized to Dilapan-S® versus Foley bulb. The investigators hypothesized that osmotic cervical dilators (Dilapan-S®) are as effective as Foley bulb catheter in rates of vaginal delivery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPre-induction Dilation of Cervix
CountriesUnited States
CollaboratorsMedicem International CR s.r.o.

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedSep 14, 2016
Enrollment StartSep 1, 2016
Primary CompletionFeb 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.8 years ago

Interventions

Dilapandevice

Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, synthetic osmotic dilators (Dilapan-S) are inserted into the cervical canal with special attention to cross through the internal os.

Foley Catheterdevice

Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, a Foley catheter is inserted into the cervix and the balloon is filled with 60 ml of sterile 0.9% NaCl.