Comparison of Foley Balloon With or Without Traction for... | NCT01063244

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

NCT01063244

Sponsor

St. Luke's Hospital, Pennsylvania

Status

Completed

Last Update Posted

Apr 18, 2016Estimated

Enrollment

65Actual

Phase

Phase 3

Conditions

Pregnancy

Interventions

foley balloon only
foley balloon with weight attached

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2012Actual

First Submitted Date

Feb 3, 2010

First Submission Date that Met QC Criteria

Feb 4, 2010

First Posted Date

Feb 5, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2016

Last Update Posted Date

Apr 18, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

James Anasti, MD, Director, OB?GYN Residency Program, St. Luke's Hospital, PennsylvaniaPrincipal Investigator

Lead Sponsor

St. Luke's Hospital, PennsylvaniaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

65Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FoleyBalloon	Active Comparator	foley balloon placed in the cervix	Device: foley balloon only
foley balloon with weight	Active Comparator	foley balloon with weight attached	Device: foley balloon with weight attached

Interventions

Name	Type	Description	Arm Group Labels	Other Names
foley balloon only	Device	place foley balloon only in cervix	FoleyBalloon

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to effectively ripen cervix		to effective cervical ripening

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Term pregnancy scheduled for induction of labor

Exclusion Criteria:

Preterm pregnancy that require induction for fetal indications

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James N Aansti, MD	St. Luke's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Luke's Hosptial & Health Network		Bethlehem	Pennsylvania	18015	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided