Bishop Score and Transvaginal Ultrasound for Preinduction Cervical Assessment in Multiparas

Failed Induction of Labor Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01317823
• Other study ID #: BS_CL_02
• Status: Completed
• Phase: N/A
• First received: March 16, 2011
• Last updated: October 21, 2012
• Start date: December 2008
• Est. completion date: April 2012

Study information

• Verified date: October 2012
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review BoardKorea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Failed Induction of Labor

Intervention

Other:
• Assessment of cervical status
Assessment of cervical status based on Bishop score versus sonographically measured cervical length

Locations

Country	Name	City	State
Korea, Republic of	Department of Obstetrics and Gynecology Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No