NCT01317706

Brief Summary

To compare the ultrasonographic cervical length with the Bishop score in determining the administration of prostaglandin for preinduction cervical ripening in nulliparas at term.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2011

Completed
Last Updated

March 17, 2011

Status Verified

March 1, 2011

Enrollment Period

1.7 years

First QC Date

March 16, 2011

Last Update Submit

March 16, 2011

Conditions

Failed Induction of Labor

Keywords

Bishop score, Cervical length, Cervical ripening, Labor induction

Outcome Measures

Primary Outcomes (1)

  • Successful labor induction

    Induction success was defined as an ability to achieve the active phase of labor corresponding to a cervical dilatation of ≥ 4 cm within 11 hours of initiating oxytocin (i.e., within 22 hours of the administration of a dinoprostone vaginal insert) on the first day of induction.

    Eleven hours of initiating oxytocin on the fist day of induction

Secondary Outcomes (1)

  • the need for oxytocin induction

    After removing prostaglandin, the following day when an intravenous oxytocin infusion was started

Study Arms (2)

Bishop score

ACTIVE COMPARATOR
Other: Assessment of cervical status

transvaginal ultrasound

ACTIVE COMPARATOR
Other: Assessment of cervical status

Interventions

Assessment of cervical statusOTHER

Assessment of cervical status based on Bishop score versus sonographically measured cervical length

Bishop scoretransvaginal ultrasound

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • nulliparous patients
  • singleton pregnancy
  • live fetus with vertex presentation
  • intact amniotic membranes
  • \> 37 weeks gestation
  • absence of labor
  • no previous uterine surgical procedures

You may not qualify if:

  • major congenital anomaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology Seoul National University Bundang Hospital

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

Location

Study Officials

  • Kyo Hoon Park, MD, PhD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 16, 2011

First Posted

March 17, 2011

Study Start

November 1, 2008

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

March 17, 2011

Record last verified: 2011-03

Locations

KR(1)