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NCT00684606 Clinical Trial

Transcervical Foley Catheter With or Without Oxytocin for Induction of Labor

Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00684606
Other study ID # SHEBA-08-5164-OM-CTIL
Secondary ID
Status Recruiting
Phase N/A
First received May 22, 2008
Last updated June 18, 2008
Start date May 2008
Est. completion date May 2010

Study information
Verified date June 2008
Source Sheba Medical Center
Contact Orit Moran, MD
Phone 972-3-5302777
Email orit.moran@sheba.health.gov.il
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date May 2010
Est. primary completion date May 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 50 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Israel Sheba medical center Ramat-Gan

Sponsors (1)
Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary The period of time needed for ripening the uterine cervix by Transcervical Foley catheter with or without IV Oxytocin infusion. year Yes
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