Single Balloon Catheter Compared With Double Balloon Catheter for Ripening of the Unfavorable Cervix

September 1, 2016 updated by: Raed Salim, HaEmek Medical Center, Israel
The purpose of this study is to compare between single balloon catheter and double balloon catheter for ripening the cervix among pregnant with unfavorable cervix.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

293

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

  • Israel
      • Afula, Israel
        • Department of Ob/Gyn, Ha'Emek Medical Center

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

18 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Induction of labor is indicated
  • Gestational age between 24 - 42 weeks
  • Singleton pregnancy
  • Bishop score less than 7

Exclusion Criteria:

  • Any contraindication for vaginal delivery
  • Previous cesarean delivery
  • Low lying placenta
  • Rupture of membranes
  • Fetal malformations incompatible with life
  • intrauterine fetal death
  • Amnionitis

  • Genital viral infection (HIV, hepatitis C virus

    , hepatitis B virus)

  • Allergy to latex

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: 1
Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter)
Device: Foley catheter
Single balloon catheter
Active Comparator: 2
Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter)
Device: Atad catheter
Double balloon catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Average Time in Hours From Insertion of the Catheter Until Delivery
Time Frame: At the end of the study
At the end of the study

Secondary Outcome Measures

Outcome Measure
Time Frame
To Compare Mode of Delivery, Catheter's Side Effects and Woman's Satisfaction Between the Groups
Time Frame: At the end of the study
At the end of the study

Collaborators and Investigators

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

Sponsor

HaEmek Medical Center, Israel

Investigators

  • Principal Investigator: Raed Salim, MD, Department of Ob/Gyn, Ha'Emek Medical Center, Afula, and Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel

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

June 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

May 31, 2008

First Submitted That Met QC Criteria

June 3, 2008

First Posted (Estimate)

June 4, 2008

Study Record Updates

Last Update Posted (Estimate)

October 24, 2016

Last Update Submitted That Met QC Criteria

September 1, 2016

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0007-08-EMC

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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