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OpenTrials
Completed

NCT Number: NCT01792375

Concurrent Membrane Sweeping With Dinoprostone Versus Dinoprostone in Labor Induction of Nulliparas at Term With an Unfavorable Cervix

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

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Key information

Conditions

Nulliparous Women Who Scheduled for Labor Induction

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

Concurrent membrane sweeping with Dinoprostone

Procedure

Women assigned to "Sweep" had their cervix swept by inserting the examining finger as high as possible past the internal cervical os, immediately followed by the placement of a 10mg Dinoprostone vaginal insert in the posterior fornix.

10mg Dinoprostone vaginal insert

Drug

For women assigned to "No sweep": The only 10mg Dinoprostone vaginal insert were placed in the posterior fornix for cervical ripening

Primary outcomes

  1. Vaginal delivery within 24 hours

    Time frame: Twenty-four hours of initiating intervention (i.e. membrane sweeping or PG) on the first day of induction

    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. Cervical change in the bishop scores and cervical lengths

    Time frame: Initiation of oxytocin after removing dinoprostone vaginal insert

    • Cervical change based on the bishop score and cervical length induced by two cervical ripening methods(concurrent membrane sweeping with dinoprostone vs. dinoprostone)
    • Incidence of cesarean delivery
    • Successful labor induction (defined as an ability to achieve the active phase of labor corresponding to a cervical dilatation of >=4cm).
    • The interval from start of oxytocin to delivery
    • Incidence of rupture of membranes
    • Incidences of vaginal bleeding and fever

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Feb 15, 2013
Registry last updated
Mar 4, 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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