NCT04220320

Brief Summary

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

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
758

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

1.2 years

First QC Date

January 5, 2020

Last Update Submit

October 24, 2022

Conditions

Induction of Labor Affected Fetus / Newborn

Outcome Measures

Primary Outcomes (1)

  • Time to delivery

    The time from induction commencement to delivery of the newborn.

    Up to 72 hours.

Secondary Outcomes (1)

  • BISHOP score after primary induction.

    Up to 24 hours.

Study Arms (3)

Classic BISHOP score

Gynecological evaluation based on vaginal examination including cervical dilatation, effacement, texture, station and position.

Diagnostic Test: Vaginal examination.

Modified BISHOP score

Gynecological evaluation based on vaginal examination including cervical dilatation and effacement alone.

Diagnostic Test: Vaginal examination.

Cervical Length

Gynecological evaluation based on cervical length measured by transvaginal sonography.

Diagnostic Test: Transvaginal sonography.

Interventions

Vaginal examination.DIAGNOSTIC_TEST

Cervical properties as evaluated by a vaginal examination.

Classic BISHOP scoreModified BISHOP score
Transvaginal sonography.DIAGNOSTIC_TEST

Cervical length as evaluated by a transvaginal sonography.

Cervical Length

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale.
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Singleton pregnancies.
  • Candidates for vaginal delivery.

You may not qualify if:

  • Multiple pregnancies.
  • Candidates for cesarean section.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam healthcare campus

Haifa, Israel

Location

MeSH Terms

Interventions

Gynecological Examination

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Roy Lauterbach, MD

    Rambam Healthcare Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 5, 2020

First Posted

January 7, 2020

Study Start

March 1, 2020

Primary Completion

April 30, 2021

Study Completion

October 1, 2022

Last Updated

October 26, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)