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Bishop Score and Transvaginal Ultrasound for Preinduction Cervical Assessment in Multiparas

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01317823
First received: March 16, 2011
Last updated: October 21, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Failed Induction of Labor
 Other: Assessment of cervical status

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Diagnostic

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Successful labor induction [ Time Frame: Eleven hours of initiating oxytocin on the fist day of induction ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • the need for oxytocin induction, percentage of patients treated with prostagladins [ Time Frame: After removing prostaglandin, the following day when an intravenous oxytocin infusion was started ] [ Designated as safety issue: No ]
    1. the interval from start of oxytocin to the active phase of labor
    2. the interval from start of oxytocin to delivery
    3. vaginal delivery within 24 hours of starting induction
    4. the incidence of cesarean delivery


Enrollment: 154
Study Start Date: December 2008
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bishop score Other: Assessment of cervical status
Assessment of cervical status based on Bishop score versus sonographically measured cervical length
Active Comparator: transvaginal ultrasound Other: Assessment of cervical status
Assessment of cervical status based on Bishop score versus sonographically measured cervical length

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • major congenital anomaly
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01317823

Locations
Korea, Republic of
Department of Obstetrics and Gynecology Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Kyo Hoon Park, MD, PhD Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01317823     History of Changes
Other Study ID Numbers: BS_CL_02
Study First Received: March 16, 2011
Last Updated: October 21, 2012
Health Authority: Korea: Institutional Review Board
Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
Multiparas, Bishop score, Cervical length, Cervical ripening

ClinicalTrials.gov processed this record on June 18, 2013