A Comparison of Transcervical Foley Catheter and Prostaglandins for Induction of Labor at Term

Seoul National University

Status: Completed

Conditions: Failed Induction of Labor

Treatments: Device: Transcervical foley catheter, Prostaglandins

Study type: Interventional

Funder types: Other

Identifiers

NCT01317862

FCB_PG_01

Details and patient eligibility

About

The purpose of this study is to assess the effectiveness and safety of transcervical foley catheter as compared to prostaglandins for preinduction cervical ripening and labor induction in term nulliparous women with unfavorable cervix.

Enrollment: 154 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• singleton pregnancy
• nulliparous women
• gestational age >= 37.0 weeks
• Bishop score <= 5
• intact amniotic membrane
• abscence of labor
• live fetus with vertex presentation
• no previous uterine surgical procedure

Exclusion criteria

• major congenital anomaly

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 2 patient groups

Transcervical foley catheter

Active Comparator group

Treatment:

Device: Transcervical foley catheter, Prostaglandins

Prostaglandins

Active Comparator group

Treatment:

Device: Transcervical foley catheter, Prostaglandins