Low-dose Vaginal Misoprostol Versus Vaginal Dinoprostone Insert for Induction of Labor

Overview

Purpose:

To compare the efficacy and safety of low-dose protocol of vaginal misoprostol and vaginal dinoprostone insert for induction of labor in women with post-term pregnancies.

Methods:

The investigators designed a prospective, randomized, open-labeled, blinded for the end-point evaluators trial including women of at least 41 weeks of gestational age with uncomplicated singleton pregnancies and Bishop score lower than 6. Participants were randomized into dinoprostone or misoprostol groups in a 1:1 ratio. Baseline maternal data and perinatal outcomes were recorded for statistical analysis. Successful vaginal delivery within 24 hours was the primary outcome variable.

Full Title of Study: “Low-dose Vaginal Misoprostol Versus Vaginal Dinoprostone Insert for Induction of Labor Beyond 41st Week: a Randomized 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: October 20, 2017

Interventions

  • Drug: Misoprostol 25 mcg
    • To determine efficacy and safety of vaginal ‘Misoprostol 25 mcg’ every 4 hours with a maximum of 6 doses for induction of labor.
  • Drug: Dinoprostone 10mg
    • To determine efficacy and safety of ‘Dinoprostone 10mg’ vaginal insert for induction of labor.

Arms, Groups and Cohorts

  • Active Comparator: Misoprostol
    • Group of women allocated to misoprostol induction.
  • Active Comparator: Dinoprostone
    • Group of women allocated to dinoprostone induction.

Clinical Trial Outcome Measures

Primary Measures

  • Successful vaginal delivery within 24 hours
    • Time Frame: 24 hours since induction was started
    • Percentage of women that achieve a vaginal delivery within 24 hours since induction process started

Secondary Measures

  • Successful cervical ripening within 24 hours
    • Time Frame: 24 hours since induction was started
    • Percentage of women that achieve Bishop score > 6 within 24 hours since induction process started
  • Interval time from induction to delivery
    • Time Frame: Hours passed between induction of labor until delivery within 72 hours
    • Time passed since induction of labor started until delivery
  • Need for a second induction
    • Time Frame: Assessed 24 hours since induction of labor was started
    • Percentage of women that require to use a second method for induction of labor after 24 hours of having started induction of labor
  • Vaginal delivery rate
    • Time Frame: Since labor induction had started until delivery had ocurred within 72 hours
    • Percentage of women that achieve vaginal delivery

Participating in This Clinical Trial

Inclusion Criteria

  • Singleton uncomplicated pregnancy
  • Nulliparity
  • Live fetus
  • 286 days of gestational age or above
  • Abscence of contraindication for vaginal delivery
  • Bishop score lower than 6

Exclusion Criteria

  • Multiple pregnancy
  • Multiparity
  • Stillbirth
  • Oligohydramnios
  • Suspected fetal distress
  • Severe asthma
  • Intolerance/allergy to prostaglandins
  • Contraindication for vaginal birth

Gender Eligibility: Female

Pregnant women

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hospital Miguel Servet
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jose Manuel Campillos Maza, Head of Unit of Maternal-Fetal Medicine – Hospital Miguel Servet

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