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OpenTrials
Completed

NCT Number: NCT02416583

Concurrent Oxytocin With Membrane Sweeping Versus Dinoprostone Pessary in Labor Induction of Nulliparas at Term

To compare concurrent oxytocin with membrane sweeping versus dinoprostone pessary in labor induction for nulliparas at term with an unfavorable cervix

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Key information

Conditions

Failed Induction of Labor

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynecology Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • singleton pregnancy
  • Nulliparous women
  • gestational age >=37.0 weeks
  • Bishop score <=6
  • intact amniotic membrane
  • absence of labor
  • live fetus with vertex presentation
  • no previous uterine surgical procedure

Exclusion criteria

  • Multiple pregnancy
  • Placenta previa

Treatment and study plan

Oxytocin

Drug

Dinoprostone

Drug

Membrane sweeping

Procedure

Primary outcomes

  1. Vaginal delivery within 24 hours

    Time frame: From the time of initiating intervention (i.e.concurrent membrane sweeping with dinoprostone or only dinoprostone) until the time of vaginal delivery, assessed up to 24 hours

    Vaginal delivery within 24 hours is defined as vaginal delivery after 24 hours of initiating intervention (i.e.concurrent membrane sweeping with dinoprostone or only dinoprostone) on the first day of induction.

Secondary outcomes

  1. Successful labor induction

    Time frame: From the time of initiating intervention (i.e.concurrent membrane sweeping with dinoprostone or only dinoprostone) until the time of active phase of labor ( defined as a cervical dilatation of >=4cm), assessed up to 24 hours

    to achieve the active phase of labor corresponding to a cervical dilatation of >=4cm

  2. Incidence of cesarean delivery

    Time frame: End of labor induction (assessed up to 120 hours)

    From the time of initiating intervention (i.e.concurrent membrane sweeping with dinoprostone or only dinoprostone) until the time of cesarean delivery, assessed up to 120 hours

  3. The interval from start of oxytocin to delivery

    Time frame: From the time of initiating oxytocin infusion until the time of delivery, assessed up to 120 hours

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 15, 2015
Registry last updated
Mar 3, 2020

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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