Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Transcervical Foley Catheter With or Without Oxytocin for Induction of Labor

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Sheba Medical Center.
Recruitment status was  Recruiting
Information provided by:
Sheba Medical Center Identifier:
First received: May 22, 2008
Last updated: June 18, 2008
Last verified: June 2008

The purpose of the present study is to evaluate the possible benefit of concurrent IV Oxytocin infusion with trans cervical Foley catheter for pre-induction cervical ripening.

Condition Intervention
Induction of Labor
Drug: Oxytocin IV

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Transcervical Foley Catheter With or Without IV Oxytocin Infusion for Induction of Labor: a Randomized Controlled Trial

Resource links provided by NLM:

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • The period of time needed for ripening the uterine cervix by Transcervical Foley catheter with or without IV Oxytocin infusion. [ Time Frame: year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: May 2008
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Transcervical Foley catheter with IV Oxytocin
Drug: Oxytocin IV
5 miu/1000ml Glu/Saline
Other Name: Pitocin
No Intervention: 2
Transcervical Foley catheter only

Detailed Description:

Induction of labor in term pregnancy may be challenging, especially in patients with unfavorable cervical conditions. Numerous trails have presented evidence of the efficacy of the trans cervical Foley catheter for pre-induction cervical ripening.The purpose of the present study is to evaluate the possible benefit of concurrent IV Oxytocin infusion with trans cervical Foley catheter for pre-induction cervical ripening.


Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Term pregnancy
  • Medical indication for labor induction by transcervical Foley catheter

Exclusion Criteria:

  • Preterm pregnancy
  • Contraindication for induction of labor by transcervical Foley catheter or by IV Oxytocin:

    • Uterine scar
    • Multiple pregnancy
    • PROM
    • Grand-multiparity
    • Placenta previa or marginal placenta
    • Spontaneous uterine contractions (more than 3 in 10 minutes)
    • Vaginal bleeding
    • Nonreassuring fetal heart rate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00684606

Contact: Orit Moran, MD 972-3-5302777
Contact: Baruch Feldman, MD, PhD 972-3-5303934

Sheba medical center Recruiting
Ramat-Gan, Israel
Contact: Orit Moran, MD    972-3-5302777   
Principal Investigator: Orit Moran, MD         
Sponsors and Collaborators
Sheba Medical Center
Principal Investigator: Orit Moran, M.D. Sheba Medical Center
  More Information

No publications provided

Responsible Party: Dr. Orit Moran, Sheba Medical Cener Identifier: NCT00684606     History of Changes
Other Study ID Numbers: SHEBA-08-5164-OM-CTIL
Study First Received: May 22, 2008
Last Updated: June 18, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Induction of Labor
Low Bishop Score
Transcervical Foley Catheter.
IV Oxytocin

Additional relevant MeSH terms:
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses processed this record on March 03, 2015