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Transcervical Foley Catheter With or Without Oxytocin for Induction of Labor

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00684606
Enrollment
120
Registered
2008-05-26
Start date
2008-05-31
Completion date
2010-05-31
Last updated
2008-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Induction of Labor, Pregnancy

Keywords

Induction of Labor, Low Bishop Score, Transcervical Foley Catheter., IV Oxytocin

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.

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.

Interventions

DRUGOxytocin IV

5 miu/1000ml Glu/Saline

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 50 Years
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

Design outcomes

Primary

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

Countries

Israel

Contacts

Primary ContactOrit Moran, MD
orit.moran@sheba.health.gov.il972-3-5302777
Backup ContactBaruch Feldman, MD, PhD
baruch.feldman@sheba.health.gov.il972-3-5303934

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026