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NCT04220320 Clinical Trial

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
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design

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.
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