Transcervical Foley Catheter With or Without Oxytocin for Induction of Labor

Sheba Medical Center

Status: Unknown

Conditions: Induction of Labor; Pregnancy

Treatments: Drug: Oxytocin IV

Study type: Interventional

Funder types: Other

Identifiers

NCT00684606

SHEBA-08-5164-OM-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 15 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

1

Experimental group

Description:

Transcervical Foley catheter with IV Oxytocin

Treatment:

Drug: Oxytocin IV

2

No Intervention group

Description:

Transcervical Foley catheter only