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Transcervical Foley Catheter With or Without Oxytocin for Induction of Labor

Sponsor
Sheba Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00684606
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
24
Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Oxytocin IV
 N/A

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

Study Type:
Interventional
Anticipated 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 1, 2008
Anticipated Primary Completion Date :
May 1, 2010
Anticipated Study Completion Date :
May 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Transcervical Foley catheter with IV Oxytocin

Drug: Oxytocin IV
5 miu/1000ml Glu/Saline
Other Names:
  • Pitocin

    		•
    No Intervention: 2

    Transcervical Foley catheter only

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 50 Years
    Sexes 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

    Locations

    Site City State Country Postal Code
    1 Sheba medical center Ramat-Gan Israel

    Sponsors and Collaborators

    • Sheba Medical Center

    Investigators

    • Principal Investigator: Orit Moran, M.D., Sheba Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00684606
    Other Study ID Numbers:
    • SHEBA-08-5164-OM-CTIL
    First Posted:
    May 26, 2008
    Last Update Posted:
    Jun 19, 2008
    Last Verified:
    Jun 1, 2008
    Keywords provided by , ,
    Induction of Labor
    Low Bishop Score
    Transcervical Foley Catheter.
    IV Oxytocin
    Additional relevant MeSH terms:
    Oxytocin

    Study Results

    No Results Posted as of Jun 19, 2008