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

Phase 4

• Conditions: Labor, Induced
• Interventions: Drug: Prostin (PGE2) tablets; Device: Foley catheter

• Registration Number: NCT02486679
• Lead Sponsor: Wolfson Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-22
• Study First Submitted QC: 2015-06-28
• Study Start: 2015-07
• Study First Posted: 2015-07-01
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-28
• Last Update Posted: 2016-04-29
• Primary Completion: 2017-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PGE2	Prostin (PGE2) tablets	Patients allocated to vaginal PGE2 (Prostin) for cervical ripening
Foley catheter	Foley catheter	Patients allocated to foley catheter placement for cervical ripening

Primary Outcome Measures

Name	Time	Method
Time to active labor	Post labor- up to 24 hours	Hours from foley cather placement or first PGE2 tablet placment to active labor, defined as cervical dilitation \>4 cm and/or cervical effacement\>80%

Secondary Outcome Measures

Name	Time	Method
Delivery within 24 hours	post-labor - up to 24 hours	Delivery within 24 hours from foley catheter /first PGE2 tablet palcement
Neonatal complications	Neonates of participants will be followed for labor course and the duration of hospital stay, up to 1 month	Documented complications such as non-reassuring fetal heart rate, fetal pH, NICU admission, early neonatal sepsis
Cesarean section rate	post labor - up to 24 hours	Delivery via cesarean section
Maternal complications	participants will be followed for labor course and the duration of hospital stay, an expected average of 5 days	Documented complications during labor, including: excessive hemmorhage, infection (chorioamnionitis)

Trial Locations

Locations (1)

Edith Wolfson Medical Center; 🇮🇱 Holon, Israel