Transcervical Foley Catheter With or Without Oxytocin for Induction of Labor

June 18, 2008 updated by: Sheba Medical Center

Transcervical Foley Catheter With or Without IV Oxytocin Infusion for Induction of Labor: a Randomized Controlled Trial

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Ramat-Gan, Israel
        • Recruiting
        • Sheba Medical Center
        • Contact:
        • Principal Investigator:
          • Orit Moran, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Anticipated)

May 1, 2010

Study Completion (Anticipated)

May 1, 2010

Study Registration Dates

First Submitted

May 22, 2008

First Submitted That Met QC Criteria

May 23, 2008

First Posted (Estimate)

May 26, 2008

Study Record Updates

Last Update Posted (Estimate)

June 19, 2008

Last Update Submitted That Met QC Criteria

June 18, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-08-5164-OM-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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