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NCT03944187 Clinical Trial

Sonographic Assessment for Prediction of Labor Induction Success

Induction of Labor Affected Fetus / Newborn Clinical Trial

Official title:
Sonographic Assessment of Fetal Head Circumference, Cervical Length and Fetal Head to Cervix Angle for Prediction of Labor Induction Success

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03944187
Other study ID # 0529-18-RMB
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2019
Est. completion date April 1, 2022

Study information
Verified date April 2022
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study is conducted to assess several sonographic parameters for prediction of labor induction success. These parameters include cervical length, fetal head circumference, and fetal head to cervix angle.

Description:

Pregnant women at term over 37 weeks' gestation visiting the obstetric emergency room for various obstetric indications will be assessed. Women with obstetric or medical indication for induction will receive an explanation regarding the study protocol and will sign an informed consent. After recruitment and during the evaluation in the obstetric emergency room, patients will undergo transvaginal sonography during which, cervical length, fetal head circumference and fetal head to cervix angle will be measured. Relevant demographic and obstetric information will be collected from a computerized database.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date April 1, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Singleton pregnancy. - Term pregnancy. Exclusion Criteria: - Multiple gestation. - Fetal anomalies and malformations. - Preterm pregnancy.

Study Design

Related Conditions & MeSH terms

  • Induction of Labor Affected Fetus / Newborn

Intervention

Diagnostic Test:
• Transvaginal sonography
Transvaginal sonography for measurement of cervical length, fetal head circumference and fetal head to cervix angle .

Locations
Country Name City State
Israel Rambam health care 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 Success in induction of labor Vaginal delivery rate after labor induction From admission to the obstetric emergency room up to 24 hours postpartum
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