The Success of Labor Induction Based on a Modified BISHOP Score.

The Success of Labor Induction Based on a Modified BISHOP Score Compared to Classic BISHOP Score and Cervical Length in Transvaginal Sonography.

Pregnant women at term will be divided randomly into 3 groups:

1. Gynecological evaluation based on classic BISHOP score.
2. Gynecological evaluation based on a modified BISHOP score.
3. Gynecological evaluation based on cervical length as measured by transvaginal sonography.

After gynecological evaluation, women will undergo induction of labor based on obstetric evaluation according to the group they were part of.

Study Overview

• Status: Completed
• Conditions: Induction of Labor Affected Fetus / Newborn
• Intervention / Treatment: Diagnostic test: Vaginal examination.; Diagnostic test: Transvaginal sonography.

Detailed Description

Women presenting to the obstetric emergency room for follow-up for various obstetric/other medical conditions over 37 weeks' gestation that are candidates for labor induction will receive an explanation regarding the study and sign informed consent.

The women will be divided randomly into 3 groups:

1. Gynecological evaluation based on classic BISHOP score.
2. Gynecological evaluation based on a modified BISHOP score.
3. Gynecological evaluation based on cervical length as measured by transvaginal sonography.

After gynecological evaluation, women will undergo induction of labor based on obstetric evaluation according to the group they were part of.

• Study Type: Observational
• Enrollment (Actual): 758

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Healthcare Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women over 37 weeks' gestation that are candidates for induction of labor for obstetric/other medical indications.

Description

Inclusion Criteria:

• Singleton pregnancies.
• Candidates for vaginal delivery.

Exclusion Criteria:

• Multiple pregnancies.
• Candidates for cesarean section.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Classic BISHOP score; Gynecological evaluation based on vaginal examination including cervical dilatation, effacement, texture, station and position.	Diagnostic test: Vaginal examination.; Cervical properties as evaluated by a vaginal examination.
Modified BISHOP score; Gynecological evaluation based on vaginal examination including cervical dilatation and effacement alone.	Diagnostic test: Vaginal examination.; Cervical properties as evaluated by a vaginal examination.
Cervical Length; Gynecological evaluation based on cervical length measured by transvaginal sonography.	Diagnostic test: Transvaginal sonography.; Cervical length as evaluated by a transvaginal sonography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to delivery	The time from induction commencement to delivery of the newborn.	Up to 72 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BISHOP score after primary induction.	BISHOP score after primary induction. BISHOP is not an abbreviation and is just the name of the score. The minimum score is 0 and the maximum score is 13. The higher the score, the more favorable the cervix is considered before induction of labor.	Up to 24 hours.

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: January 5, 2020
• First Submitted That Met QC Criteria: January 5, 2020
• First Posted (Actual): January 7, 2020

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 0622-19-RMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No