Transcervical Foley Catheter With or Without Oxytocin for Induction of Labor
Information source: Sheba Medical Center
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pregnancy; Induction of Labor
Intervention: Oxytocin IV (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Sheba Medical Center Official(s) and/or principal investigator(s):
Orit Moran, M.D., Principal Investigator, Affiliation: Sheba Medical Center
Overall contact:
Orit Moran, MD, Phone: 972-3-5302777, Email: orit.moran@sheba.health.gov.il
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.
Clinical Details
Official title: Transcervical Foley Catheter With or Without IV Oxytocin Infusion for Induction of Labor: a Randomized Controlled Trial
Study design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: The period of time needed for ripening the uterine cervix by Transcervical Foley catheter with or without IV Oxytocin infusion.
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
Minimum age: 15 Years.
Maximum age: 50 Years.
Gender(s): Female.
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
Locations and Contacts
Orit Moran, MD, Phone: 972-3-5302777, Email: orit.moran@sheba.health.gov.il
Sheba medical center, Ramat-Gan, Israel; Recruiting
Orit Moran, MD, Phone: 972-3-5302777, Email: orit.moran@sheba.health.gov.il
Orit Moran, MD, Principal Investigator
Additional Information
Starting date: May 2008
Last updated: June 18, 2008
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