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

June 9, 2010 updated by: Municipal Hospital Vila Nova Cachoeirinha

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The cesarean delivery rate has risen dramatically in almost all world. Brazil shows the highest rate in the world so we need urgently efforts to reduce this fact. Several studies have shown that maternal morbidity and mortality rates are higher in cesarean deliveries. On the other hand an abdominal delivery cost much more than a vaginal delivery.

A clinical trial to assess the performance of two simple and sheep methods can provide evidence based on local experience. Our results alow us to recommend both methods for clinical practice with a good possibility to reduce cesarean rates and without adverse events.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 02720-200
        • MHVNCachoeirinha

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Gestational age from 37 weeks,
  • feto unic, alive and cephalic,
  • Bishop index equal or lesser than four.

Exclusion Criteria:

  • uterine scar,
  • premature rupture of the membranes,
  • fetal weight bigger than 4000 g,
  • previous placenta,
  • conditions that imposed the immediate ending of the gestation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Misoprostol
Use 25 micrograms vaginal every 6 hours (max dosis 200 micrograms in 48 hours)
Drug: Misoprostol
Vaginal application of 25 micrograms every 6 hours until cervical ripening reach Bishop 6 or more
Other Names:
  • Prostokos 25 micrograms
Active Comparator: Foley
Foley catheter number 14 or 16 was installed intracervical for no more than 48 hours.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cervical ripening
Time Frame: 48 hous after start the method

Foley Group: catheter stay no more that 48 hours. 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.

Misoprostol group: was introduced 25 microgram every 6 hour (max 200microg)if cervical conditions were unchanged. In the case of cervical evolution or start of labour the method was considered success.The failure was adopted if after 48 there was no cervical modifications.
48 hous after start the method

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cesarean
Time Frame: The action of methods were assessed for 48 hours after start.
After 48 hours if there was no cervical ripening or espontaneous labor the case was classified as failure of method and a cesarean was performed
The action of methods were assessed for 48 hours after start.
Need of oxytocin
Time Frame: 48 hours after start method
In cases on the cervical ripening had occurred but the spontaneous labor not start.
48 hours after start method
need of neonatal intensive care
Time Frame: 7 first days after birth
The condition of babies at birth and needs of intensive care as mechanic ventilation or others interventions.
7 first days after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Municipal Hospital Vila Nova Cachoeirinha

Investigators

  • Principal Investigator: Nelson Sass, pHD, Maternidade Escola de Vila Nova Cachoeirinha

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

June 8, 2010

First Submitted That Met QC Criteria

June 9, 2010

First Posted (Estimate)

June 10, 2010

Study Record Updates

Last Update Posted (Estimate)

June 10, 2010

Last Update Submitted That Met QC Criteria

June 9, 2010

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHVNCachoeirinha

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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