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

Overview

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

Full Title of Study: “Cervical Ripening at Term With Prostaglandin E2 Tablets Versus Foley Catheter: a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: July 2017

Interventions

  • Drug: Prostin (PGE2) tablets
  • Device: Foley catheter

Arms, Groups and Cohorts

  • Active Comparator: PGE2
    • Patients allocated to vaginal PGE2 (Prostin) for cervical ripening
  • Active Comparator: Foley catheter
    • Patients allocated to foley catheter placement for cervical ripening

Clinical Trial Outcome Measures

Primary Measures

  • Time to active labor
    • Time Frame: 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 Measures

  • Delivery within 24 hours
    • Time Frame: post-labor – up to 24 hours
    • Delivery within 24 hours from foley catheter /first PGE2 tablet palcement
  • Cesarean section rate
    • Time Frame: post labor – up to 24 hours
    • Delivery via cesarean section
  • Maternal complications
    • Time Frame: 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)
  • Neonatal complications
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Wolfson Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hadas Ganer Herman, MD – Wolfson Medical Center
  • Overall Contact(s)
    • Hadas Ganer Herman, MD, 972526206696, hadassganer@yahoo.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.