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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:
ClinicalTrials.gov Identifier:
NCT00684606
First Posted: May 26, 2008
Last Update Posted: June 19, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sheba Medical Center
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00684606


Contacts
Contact: Orit Moran, MD 972-3-5302777 orit.moran@sheba.health.gov.il
Contact: Baruch Feldman, MD, PhD 972-3-5303934 baruch.feldman@sheba.health.gov.il

Locations
Israel
Sheba medical center Recruiting
Ramat-Gan, Israel
Contact: Orit Moran, MD    972-3-5302777    orit.moran@sheba.health.gov.il   
Principal Investigator: Orit Moran, MD         
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
First Submitted: May 22, 2008
First Posted: May 26, 2008
Last Update Posted: June 19, 2008
Last Verified: June 2008

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