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

NCT ID: NCT01063244

Last Updated: 2016-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-01-31

Brief Summary

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We will compare the use of foley bulb catheters placed in the cervix for ripening of the cervix for labor induction,.

Detailed Description

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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

Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FoleyBalloon

foley balloon placed in the cervix

Group Type ACTIVE_COMPARATOR

foley balloon only

Intervention Type DEVICE

place foley balloon only in cervix

foley balloon with weight

foley balloon with weight attached

Group Type ACTIVE_COMPARATOR

foley balloon with weight attached

Intervention Type DEVICE

foley balloon with 1000cc IV bag attached

Interventions

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foley balloon only

place foley balloon only in cervix

Intervention Type DEVICE

foley balloon with weight attached

foley balloon with 1000cc IV bag attached

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Term pregnancy scheduled for induction of labor

Exclusion Criteria

* Preterm pregnancy that require induction for fetal indications
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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St. Luke's Hospital, Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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James Anasti, MD

Director, OB?GYN Residency Program

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James N Aansti, MD

Role: PRINCIPAL_INVESTIGATOR

St. Luke's Hospital

Locations

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St Luke's Hosptial & Health Network

Bethlehem, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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SLHN-08-21

Identifier Type: -

Identifier Source: org_study_id

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