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

Induction of Labor Affected Fetus / Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04220320
• Other study ID #: 0622-19-RMB
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: October 1, 2022

Study information

• Verified date: October 2022
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 758
• Est. completion date: October 1, 2022
• Est. primary completion date: April 30, 2021
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Singleton pregnancies.

• Candidates for vaginal delivery.

Exclusion Criteria:

• Multiple pregnancies.

• Candidates for cesarean section.

Related Conditions & MeSH terms

• Induction of Labor Affected Fetus / Newborn

Intervention

Diagnostic Test:
• Vaginal examination.
Cervical properties as evaluated by a vaginal examination.
• Transvaginal sonography.
Cervical length as evaluated by a transvaginal sonography.

Locations

Country	Name	City	State
Israel	Rambam healthcare campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to delivery	The time from induction commencement to delivery of the newborn.	Up to 72 hours.
Secondary	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.