NCT00290199

Brief Summary

In women undergoing labor induction for membrane rupture at or near term, we are investigating the addition of a foley catheter placed in the cervix to standard therapy (oxytocin administration) to decrease the time from the start of the induction to delivery.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
169

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2005

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
terminated

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

December 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

October 31, 2012

Completed
Last Updated

May 23, 2017

Status Verified

April 1, 2017

Enrollment Period

2.4 years

First QC Date

February 9, 2006

Results QC Date

June 1, 2012

Last Update Submit

April 12, 2017

Conditions

Fetal Membranes, Premature RuptureLabor, Induced/IS

Keywords

Fetal Membranes, Premature RuptureLabor, InducedFoley Catheter

Outcome Measures

Primary Outcomes (1)

  • Hours From Placement of Foley or Initiation of Oxytocin to Delivery

    The outcome measure is the mean in hours of the time from induction to delivery (up to 24 hours)

    Time from induction to delivery

Secondary Outcomes (3)

  • Rate of Delivery (Vaginal or Cesarean)by 24 Hours

    from start of induction to 24 hours post start of induction

  • Cesarean Rate

    at delivery

  • Induction to Vaginal Delivery Interval

    time from induction to vaginal delivery, up to 24 hours

Study Arms (2)

Transcervical Foley Catheter

EXPERIMENTAL
Device: Transcervical Foley catheter

No Foley

NO INTERVENTION

Interventions

Transcervical Foley catheterDEVICE

Foley catheter placed through cervix for cervical ripening

Transcervical Foley Catheter

Eligibility Criteria

Age12 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Preterm rupture of membranes (PROM) (Rupture of membranes = pooling/ferning/nitrazine +) Rupture of membranes (ROM) for ≥1 hour prior to starting induction
  • Cervix ≤ 2 centimeters (cm)
  • Gestational age ≥ 34 weeks by best obstetric estimate and clinical management decision is delivery
  • Singleton gestation
  • Cephalic
  • Vertex well applied to cervix

You may not qualify if:

  • Regular uterine contractions (contractions more frequent than every 5 minutes)
  • Two prior transverse uterine incisions/vertical uterine incision/ transmural myomectomy or any obstetric contraindication to labor
  • Evidence of chorioamnionitis (temperature of 100.4°F with uterine tenderness and maternal or fetal tachycardia or purulent discharge)
  • Lethal fetal anomalies
  • Intrauterine fetal demise (IUFD)
  • Previa
  • Suspected abruption/significant hemorrhage
  • Non-reassuring fetal heart rate (FHR) pattern
  • Non vertex fetal presentation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

Christiana Care Health System

Newark, Delaware, 19713, United States

Location

Greenville Hospital System University Medical Center

Greenville, South Carolina, 29605, United States

Location

Related Publications (2)

  • Wolff K, Swahn ML, Westgren M. Balloon catheter for induction of labor in nulliparous women with prelabor rupture of the membranes at term. A preliminary report. Gynecol Obstet Invest. 1998;46(1):1-4. doi: 10.1159/000009986.

    PMID: 9692332BACKGROUND

  • 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

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Results Point of Contact

Title
Dr. Alan Tita
Organization
UAB
atita@uab.edu
205-934-9616

Study Officials

  • Alan T Tita, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof

Study Record Dates

First Submitted

February 9, 2006

First Posted

February 10, 2006

Study Start

December 1, 2005

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

May 23, 2017

Results First Posted

October 31, 2012

Record last verified: 2017-04

Locations

US(3)