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

This study has been completed.

Sponsor:

Information provided by:

Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT01317706

First received: March 16, 2011

Last updated: NA

Last verified: March 2011

History: No changes posted

Purpose

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	Intervention
Failed Induction of Labor	Other: Assessment of cervical status


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider) 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 ]
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 [ 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


Enrollment:	154
Study Start Date:	November 2008
Study Completion Date:	August 2010
Primary Completion Date:	August 2010 (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


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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Please refer to this study by its ClinicalTrials.gov identifier: 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


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
Study First Received:	March 16, 2011
Last Updated:	March 16, 2011

Keywords provided by Seoul National University Hospital:


Bishop score, Cervical length, Cervical ripening, Labor induction

ClinicalTrials.gov processed this record on July 24, 2017

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