NCT01063244

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at below P25 for phase_3 pregnancy

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

April 18, 2016

Status Verified

April 1, 2016

Enrollment Period

3 years

First QC Date

February 3, 2010

Last Update Submit

April 14, 2016

Conditions

Pregnancy

Keywords

pregnancyinduction of LaborCervical ripeningFoley balloon

Outcome Measures

Primary Outcomes (1)

  • Time to effectively ripen cervix

    to effective cervical ripening

Study Arms (2)

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

foley balloon onlyDEVICE

place foley balloon only in cervix

FoleyBalloon
foley balloon with weight attachedDEVICE

foley balloon with 1000cc IV bag attached

foley balloon with weight

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Term pregnancy scheduled for induction of labor

You may not qualify if:

  • Preterm pregnancy that require induction for fetal indications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Luke's Hosptial & Health Network

Bethlehem, Pennsylvania, 18015, United States

Location

Study Officials

  • James N Aansti, MD

    St. Luke's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, OB?GYN Residency Program

Study Record Dates

First Submitted

February 3, 2010

First Posted

February 5, 2010

Study Start

January 1, 2009

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

April 18, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)