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Transcervical Foley Catheter With or Without Oxytocin for Induction of Labor

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by Sheba Medical Center.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00684606
First received: May 22, 2008
Last updated: June 18, 2008
Last verified: June 2008
  Purpose
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
Pregnancy
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.
  Eligibility

Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT00684606

Locations
Israel
Sheba medical center
Ramat-Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Orit Moran, M.D. Sheba Medical Center
  More Information

Responsible Party: Dr. Orit Moran, Sheba Medical Cener
ClinicalTrials.gov 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:
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 07, 2016