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


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


  • 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

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