NCT00366951

Brief Summary

Our purpose was to compare the efficacy and safety of Foley catheter with oxytocin and extraamniotic saline infusion with oxytocin for induction of labor requiring cervical ripening.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2004

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

April 1, 2004

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 22, 2006

Completed
Last Updated

January 10, 2008

Status Verified

December 1, 2007

First QC Date

August 18, 2006

Last Update Submit

December 28, 2007

Conditions

Cervical RipeningLabor, Induced

Keywords

Cervical RipeningLabor, InducedBalloon DilationOxytocin

Outcome Measures

Primary Outcomes (1)

  • The time interval from placement of Foley catheter to vaginal delivery

Secondary Outcomes (3)

  • Cesarean delivery rate

  • Incidence of maternal complications

  • Incidence of neonatal complications

Interventions

Foley catheter onlyPROCEDURE
Extraamniotic saline infusionPROCEDURE

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • singleton gestation
  • cephalic vertex presentation
  • intact membrane
  • gestational age between 30 and 42 weeks
  • Bishop score less than or equal to 5

You may not qualify if:

  • suspected chorioamnionitis
  • placenta previa
  • low lying placenta
  • unexplained vaginal bleeding
  • intrauterine fetal demise
  • HIV
  • any contraindication to vaginal delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

  • 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

Study Officials

  • Yukmei R Lam, MD

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 18, 2006

First Posted

August 22, 2006

Study Start

April 1, 2004

Study Completion

November 1, 2005

Last Updated

January 10, 2008

Record last verified: 2007-12

Locations

US(1)