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Transcervical Foley Catheter With or Without Oxytocin for Induction of Labor

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.
 
ClinicalTrials.gov Identifier: NCT00684606
Recruitment Status : Unknown
Verified June 2008 by Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : May 26, 2008
Last Update Posted : June 19, 2008
Sponsor:
Information provided by:
Sheba Medical Center

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Pregnancy Induction of Labor Drug: Oxytocin IV Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
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
Study Start Date : May 2008
Estimated Primary Completion Date : May 2010
Estimated Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arms and Interventions
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Arm Intervention/treatment
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


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

Eligibility Criteria
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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
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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
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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
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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
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Principal Investigator: Orit Moran, M.D. Sheba Medical Center
More Information
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Responsible Party: Dr. Orit Moran, Sheba Medical Cener
ClinicalTrials.gov Identifier: NCT00684606    
Other Study ID Numbers: SHEBA-08-5164-OM-CTIL
First Posted: May 26, 2008    Key Record Dates
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:
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Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs