NCT01317823

Brief Summary

To compare the ultrasonographic cervical length with the Bishop score in determining the administration of prostaglandin for preinduction cervical ripening in multiparous women 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 Dec 2008

Longer than P75 for not_applicable

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

December 1, 2008

Completed
2.3 years 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
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

October 23, 2012

Status Verified

October 1, 2012

Enrollment Period

3.3 years

First QC Date

March 16, 2011

Last Update Submit

October 21, 2012

Conditions

Failed Induction of Labor

Keywords

Multiparas, Bishop score, Cervical length, Cervical ripening

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, percentage of patients treated with prostagladins

    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:

  • multiparous 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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2011

First Posted

March 17, 2011

Study Start

December 1, 2008

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

October 23, 2012

Record last verified: 2012-10

Locations

KR(1)