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OpenTrials
Completed

NCT Number: NCT03744364

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

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.

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Key information

Conditions

Induced Labor Cervical Ripening Obstetric Labor Pregnancy

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol 25 mcg

Drug

To determine efficacy and safety of vaginal 'Misoprostol 25 mcg' every 4 hours with a maximum of 6 doses for induction of labor.

Other names: Misoprostol induction

Dinoprostone 10mg

Drug

To determine efficacy and safety of 'Dinoprostone 10mg' vaginal insert for induction of labor.

Other names: Dinoprostone induction

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. Vaginal delivery rate

    Time frame: Since labor induction had started until delivery had ocurred within 72 hours

    Percentage of women that achieve vaginal delivery

Sponsors and collaborators

Lead sponsor

Hospital Miguel Servet

Other

Registry information

Official study title

Low-dose Vaginal Misoprostol Versus Vaginal Dinoprostone Insert for Induction of Labor Beyond 41st Week: a Randomized Trial

Acronym: MADUTER

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 16, 2018
Registry last updated
Nov 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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