NCT00442663

Brief Summary

The purpose of this study is to compare the efficacy of a transcervical Foley catheter with and without extra-amniotic saline infusion (EASI) for priming the cervix for labor.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2003

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

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

June 1, 2003

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 2, 2007

Completed
Last Updated

April 24, 2007

Status Verified

April 1, 2007

First QC Date

February 28, 2007

Last Update Submit

April 23, 2007

Conditions

Labor InductionCervical Ripening

Keywords

Labor InductionCervical RipeningFoley Catheter

Outcome Measures

Primary Outcomes (1)

  • Time from the start of labor induction to delivery

Secondary Outcomes (1)

  • Secondary maternal outcomes included cesarean delivery, chorioamnionitis and endometritis. Neonatal outcomes included birthweight, Apgar scores and cord blood gas analysis

Interventions

Transcervical Foley CatheterDEVICE
Transcervical Foley Catheter with an EASIDEVICE

Eligibility Criteria

Age15 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Singleton pregnancy
  • weeks of gestation
  • Cephalic presentation
  • Intact membranes
  • Bishop score of less than or equal to 6

You may not qualify if:

  • Contraindications to labor
  • Dead or severely anomalous fetus
  • Spontaneous labor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

Truman Medical Center

Kansas City, Kansas, 64108, United States

Location

Saint Luke's Hospital

Kansas City, Kansas, 64111, United States

Location

Greenville Hospital System, University Medical Center

Greenville, South Carolina, 29605, United States

Location

Related Publications (4)

  • Guinn DA, Davies JK, Jones RO, Sullivan L, Wolf D. Labor induction in women with an unfavorable Bishop score: randomized controlled trial of intrauterine Foley catheter with concurrent oxytocin infusion versus Foley catheter with extra-amniotic saline infusion with concurrent oxytocin infusion. Am J Obstet Gynecol. 2004 Jul;191(1):225-9. doi: 10.1016/j.ajog.2003.12.039.

    PMID: 15295370BACKGROUND

  • Karjane NW, Brock EL, Walsh SW. Induction of labor using a foley balloon, with and without extra-amniotic saline infusion. Obstet Gynecol. 2006 Feb;107(2 Pt 1):234-9. doi: 10.1097/01.AOG.0000198629.44186.c8.

    PMID: 16449106BACKGROUND

  • de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

    PMID: 36996264DERIVED

  • Lin MG, Reid KJ, Treaster MR, Nuthalapaty FS, Ramsey PS, Lu GC. Transcervical Foley catheter with and without extraamniotic saline infusion for labor induction: a randomized controlled trial. Obstet Gynecol. 2007 Sep;110(3):558-65. doi: 10.1097/01.AOG.0000278077.30890.87.

    PMID: 17766600DERIVED

Study Officials

  • Monique G Lin, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

  • George Lu, MD

    Obstetrix Medical Group of Kansas City

    PRINCIPAL INVESTIGATOR

  • Patrick S Ramsey, MD, MSPH

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 28, 2007

First Posted

March 2, 2007

Study Start

June 1, 2003

Study Completion

December 1, 2005

Last Updated

April 24, 2007

Record last verified: 2007-04

Locations

US(4)