Bishop Score and Transvaginal Ultrasound for Preinduction Cervical Assessment in Multiparas

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.

Study Overview

• Status: Completed
• Conditions: Failed Induction of Labor
• Intervention / Treatment: Other: Assessment of cervical status

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
      • Department of Obstetrics and Gynecology Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
the need for oxytocin induction, percentage of patients treated with prostagladins	the interval from start of oxytocin to the active phase of labor; the interval from start of oxytocin to delivery; vaginal delivery within 24 hours of starting induction; the incidence of cesarean delivery	After removing prostaglandin, the following day when an intravenous oxytocin infusion was started

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Kyo Hoon Park, MD, PhD, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: March 16, 2011
• First Submitted That Met QC Criteria: March 16, 2011
• First Posted (Estimate): March 17, 2011

Study Record Updates

• Last Update Posted (Estimate): October 23, 2012
• Last Update Submitted That Met QC Criteria: October 21, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Multiparas, Bishop score, Cervical length, Cervical ripening
• Other Study ID Numbers: BS_CL_02