NCT00468520

Brief Summary

The transcervical Foley catheter (TFC) is a proven and effective mode of cervical ripening. It is common practice to use TFC with simultaneous low-dose oxytocin under the assumption that the combination results in a more successful labor induction. Scientific validation of this practice is lacking. We seek to determine if the addition of oxytocin to TFC improves induction success.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Nov 2003

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2007

Completed
Last Updated

March 2, 2011

Status Verified

February 1, 2011

First QC Date

May 1, 2007

Last Update Submit

February 28, 2011

Conditions

PregnancyInduced LaborCervical Ripening

Keywords

induction of laborcervical ripeningFoley catheteroxytocin

Outcome Measures

Primary Outcomes (1)

  • Delivery rate (proportion)

    Within 24 hours

Secondary Outcomes (4)

  • vaginal delivery rate

    within 24 hours

  • use of anesthesia/analgesia

    during induction and labor

  • overall complication rate (composite)

  • duration of induction and labor

Interventions

low dose oxytocinDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • singleton gestation
  • presenting for induction as determined by their primary obstetrical provider
  • with fetuses in cephalic presentation
  • gestational age greater than 23 weeks

You may not qualify if:

  • any condition precluding vaginal delivery
  • estimated fetal weight \>4500 grams
  • a previous attempt at ripening or induction during the pregnancy
  • clinically significant cervical or vaginal infection
  • chorioamnionitis
  • HIV
  • hepatitis B or C
  • unexplained vaginal bleeding
  • low-lying placenta
  • abnormal cervical anatomy or cervical cerclage
  • latex allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10068, United States

Location

Related Publications (1)

  • Pettker CM, Pocock SB, Smok DP, Lee SM, Devine PC. Transcervical Foley catheter with and without oxytocin for cervical ripening: a randomized controlled trial. Obstet Gynecol. 2008 Jun;111(6):1320-6. doi: 10.1097/AOG.0b013e31817615a0.

    PMID: 18515515DERIVED

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Patricia C Devine, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 1, 2007

First Posted

May 2, 2007

Study Start

November 1, 2003

Study Completion

October 1, 2005

Last Updated

March 2, 2011

Record last verified: 2011-02

Locations

US(1)