Foley Catheter Versus Dinoprostone Vaginal Insert for Induction of Labor in Parous Women at Term: A Randomized Trial

Seoul National University

Status: Completed

Conditions: Failed Induction of Labor

Treatments: Device: Transcervical foley catheter; Drug: Dinoprostone 10mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01596296

FCB_PG_parous women

Details and patient eligibility

About

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

Enrollment: 154 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• singleton pregnancy
• parous women
• gestational age >=37.0 weeks
• Bishop score <=5
• intact amniotic membrane
• absence 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

Dinoprostone

Active Comparator group

Treatment:

Drug: Dinoprostone 10mg