Comparison of Foley Balloon With or Without Traction for the Cervical Ripening

April 14, 2016 updated by: James Anasti, MD, St. Luke's Hospital, Pennsylvania
We will compare the use of foley bulb catheters placed in the cervix for ripening of the cervix for labor induction,.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

One arm will have the foley balloon placed alone in the cervix. And one arm will have the foley balloon placed in the cervix and then attached to a weight (1000 cc Iv Bag of fluid). Our hypothesis is that the weighted balloon will be more effective than the non-weighted balloon in the ripening of the cervix for induction of labor

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 3

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

  • United States
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • St Luke's Hosptial & Health Network

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 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Term pregnancy scheduled for induction of labor

Exclusion Criteria:

  • Preterm pregnancy that require induction for fetal indications

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: FoleyBalloon
foley balloon placed in the cervix
Device: foley balloon only
place foley balloon only in cervix
Active Comparator: foley balloon with weight
foley balloon with weight attached
Device: foley balloon with weight attached
foley balloon with 1000cc IV bag attached

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to effectively ripen cervix
Time Frame: to effective cervical ripening
to effective cervical ripening

Collaborators and Investigators

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

Sponsor

St. Luke's Hospital, Pennsylvania

Investigators

  • Principal Investigator: James N Aansti, MD, St. Luke's Hospital

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, 2009

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

February 3, 2010

First Submitted That Met QC Criteria

February 4, 2010

First Posted (Estimate)

February 5, 2010

Study Record Updates

Last Update Posted (Estimate)

April 18, 2016

Last Update Submitted That Met QC Criteria

April 14, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SLHN-08-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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