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Comparison Between Ultrasonographic Cervical Length and Bishop Score in Preinduction Cervical Assessment

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ClinicalTrials.gov Identifier: NCT01317706
Recruitment Status : Completed
First Posted : March 17, 2011
Last Update Posted : March 17, 2011
Sponsor:
Information provided by:
Seoul National University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Failed Induction of Labor Other: Assessment of cervical status Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Diagnostic
Study Start Date : November 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Successful labor induction [ Time Frame: Eleven hours of initiating oxytocin on the fist day of 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.


Secondary Outcome Measures :
  1. the need for oxytocin induction [ Time Frame: After removing prostaglandin, the following day when an intravenous oxytocin infusion was started ]
    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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • nulliparous 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01317706


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Seoul National University Bundang Hospital, Department of Obstetrics and Gynecology, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01317706     History of Changes
Other Study ID Numbers: BS_CL_01
First Posted: March 17, 2011    Key Record Dates
Last Update Posted: March 17, 2011
Last Verified: March 2011

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