A Trial of Prostaglandin E2 Tablets Versus Foley Catheter for Labor Induction

Wolfson Medical Center (WMC)

Status and phase: Unknown; Phase 4

Conditions: Labor, Induced

Treatments: Device: Foley catheter; Drug: Prostin (PGE2) tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT02486679

0095-15-WOMC

Details and patient eligibility

About

A randomized controlled trial comparing labor induction with vaginal PGE2 tablets and foley catheter for cervical ripening.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Singleton term pregnancies (>37 weeks), vertex presentation
• Intact membranes
• Low Bishop score (<7)
• First, second or third delivery
• Medical indication for induction
• Viable fetus

Exclusion criteria

• Contraindication for vaginal delivery, for PGE2 or foley catheter
• Gestational age<37 weeks, premature rupture of membranes, fetal or uterine malformations, previous cesarean section, uncertain dating, unwilling to participate in trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

PGE2

Active Comparator group

Description:

Patients allocated to vaginal PGE2 (Prostin) for cervical ripening

Treatment:

Drug: Prostin (PGE2) tablets

Foley catheter

Active Comparator group

Description:

Patients allocated to foley catheter placement for cervical ripening

Treatment:

Device: Foley catheter