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

Completed

• Conditions: Induction of Labor Affected Fetus / Newborn
• Interventions: Diagnostic Test: Vaginal examination.; Diagnostic Test: Transvaginal sonography.

• Registration Number: NCT04220320
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-01-05
• Study First Submitted QC: 2020-01-05
• Study First Posted: 2020-01-07
• Study Start: 2020-03-01
• Primary Completion: 2021-04-30
• Status Verified: 2022-10
• Study Completion: 2022-10-01
• Last Update Submitted: 2022-10-24
• Last Update Posted: 2022-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 758

Inclusion Criteria

• Singleton pregnancies.
• Candidates for vaginal delivery.

Exclusion Criteria

• Multiple pregnancies.
• Candidates for cesarean section.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Modified BISHOP score	Vaginal examination.	Gynecological evaluation based on vaginal examination including cervical dilatation and effacement alone.
Classic BISHOP score	Vaginal examination.	Gynecological evaluation based on vaginal examination including cervical dilatation, effacement, texture, station and position.
Cervical Length	Transvaginal sonography.	Gynecological evaluation based on cervical length measured by transvaginal sonography.

Primary Outcome Measures

Name	Time	Method
Time to delivery	Up to 72 hours.	The time from induction commencement to delivery of the newborn.

Secondary Outcome Measures

Name	Time	Method
BISHOP score after primary induction.	Up to 24 hours.	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.

Trial Locations

Locations (1)

Rambam healthcare campus; 🇮🇱 Haifa, Israel