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Foley Catheter Versus Vaginal Misoprostol for Cervical Ripening and Induction of Labor

NCT01140971 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2010-06-10

No results posted yet for this study

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.

Conditions

  • Pregnancy, Prolonged
  • Pre Eclampsia
  • Oligohydramnios

Interventions

DRUG

Misoprostol

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

DEVICE

Foley

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.

Sponsors & Collaborators

  • Municipal Hospital Vila Nova Cachoeirinha

    lead OTHER

Principal Investigators

  • Nelson Sass, pHD · Maternidade Escola de Vila Nova Cachoeirinha

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2008-03-31
Completion
2009-01-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01140971 on ClinicalTrials.gov