CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 180 enrolled
Drug / intervention
Misoprostol +1 moredrug
Likely dose
Misoprostol 25 microgramsfrom 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/NCT01140971
NCT01140971N/ACompleted
CompareCT.gov

TRANSCERVICAL FOLEY CATHETER (FOLEY) Versus INTRAVAGINAL MISOPROSTOL FOR CERVICAL RIPENING AND INDUCTION OF LABOR: A RANDOMIZED CLINICAL TRIAL.

Municipal Hospital Vila Nova Cachoeirinha·interventional·Posted Jun 10, 2010·Updated Jun 10, 2010

In Brief

A clinical study evaluating Misoprostol and Foley for Pregnancy, Prolonged and 2 related conditions. Completed, enrolled 180 participants across 1 site.

Detailed Summary

PURPOSE: The purpose of this study is to determine the effectiveness of balloon dilatation (Foley) with vaginal misoprostol for cervical ripening and induction of labor. METHOD: a randomized clinical assay has been performed with 160 women with indication of induction of labor, randomly divided in two groups, 80 for Foley catheter and 80 for misoprostol.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPregnancy, Prolonged, Pre Eclampsia, Oligohydramnios
CountriesBrazil
Collaborators--

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 10, 2010
Enrollment StartJan 1, 2006
Primary CompletionMar 1, 2008
Study CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 16.1 years ago

Interventions

Misoprostoldrug

Vaginal application of 25 micrograms every 6 hours until cervical ripening reach Bishop 6 or more

Foleydevice

After Foley introduction, every 6 hours vaginal exam was performed. The cases on Bishop score increase or occurred spontaneous exit of catheter or spontaneous labour had been initiated are considered success.The failure was adopted if after48 hours occurred no cervical modifications.