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

Labor, Induced Clinical Trial

Official title:

Cervical Ripening at Term With Prostaglandin E2 Tablets Versus Foley Catheter: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02486679
• Other study ID #: 0095-15-WOMC
• Status: Recruiting
• Phase: Phase 4
• First received: June 22, 2015
• Last updated: April 28, 2016
• Start date: July 2015
• Est. completion date: July 2017

Study information

• Verified date: April 2016
• Source: Wolfson Medical Center
• Contact: Hadas Ganer Herman, MD
• Phone: 972526206696
• Email: hadassganer[@]yahoo.com
• Is FDA regulated: No
• Health authority: Israel: ethics comission
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor, Induced

Intervention

Drug:
• Prostin (PGE2) tablets

Device:
• Foley catheter

Locations

Country	Name	City	State
Israel	Edith Wolfson Medical Center	Holon

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to active labor	Hours from foley cather placement or first PGE2 tablet placment to active labor, defined as cervical dilitation >4 cm and/or cervical effacement>80%	Post labor- up to 24 hours	No
Secondary	Delivery within 24 hours	Delivery within 24 hours from foley catheter /first PGE2 tablet palcement	post-labor - up to 24 hours	No
Secondary	Cesarean section rate	Delivery via cesarean section	post labor - up to 24 hours	No
Secondary	Maternal complications	Documented complications during labor, including: excessive hemmorhage, infection (chorioamnionitis)	participants will be followed for labor course and the duration of hospital stay, an expected average of 5 days	Yes
Secondary	Neonatal complications	Documented complications such as non-reassuring fetal heart rate, fetal pH, NICU admission, early neonatal sepsis	Neonates of participants will be followed for labor course and the duration of hospital stay, up to 1 month	Yes