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NCT01882738 Clinical Trial

Effect of Maternal BMI on Measurement of Cervical Length

PREGNANCY Clinical Trial

Official title:
Effect of Maternal BMI on Accuracy of Measurement of Cervical Length During the 3rd Trimester of Pregnancy

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01882738
Other study ID # 0039-13-HYMC
Secondary ID
Status Not yet recruiting
Phase N/A
First received June 11, 2013
Last updated June 18, 2013
Start date July 2013
Est. completion date July 2015

Study information
Verified date June 2013
Source Hillel Yaffe Medical Center
Contact Alon Shrim, MD
Phone +972-50-6246988
Email alon.shrim@gmail.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial Summary

All consecutive pregnant patients in 2nd or 3rd trimester will be asked to participate. Cervical length will be assessed in all patients, once abdominally and then vaginally (that would serve as golden standard). Correlation would be assessed between accuracy of measurement to BMI

Description:

This study will include pregnant women in either 2nd or 3rd trimester of pregnancy. All consecutive pregnant patients in 2nd or 3rd trimester who will attend our unit for routine ultrasound exam will be asked to participate. Cervical length will be assessed in all patients, once abdominally and then vaginally (that would serve as golden standard). Correlation would be assessed between accuracy of measurement to BMI. Accuracy would be defind as the delta of cervical length between abdominal and vaginal routs.

BMI would be calculated prior to the ultrasound exam (by weighing and measuring all patients).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 300
Est. completion date July 2015
Est. primary completion date July 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- All pregnant women in 2nd or 3rd trimester who attend routine ultrasound exam

Exclusion Criteria:

- Known shore cervix

- PPROM

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Hillel Yaffe Medical Center Hadera

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Accuracy of cervical length according to BMI the golden standard for cervical length measurement is vaginal scan. Our outcome measure will be the accuracy of cervical length measurement - measured abdominally, according to BMI. I other words - was there a difference between measurement by vaginal probe and abdominal probe and whether this difference correlates with BMI 1 year No
Secondary Gestational age at delivery according to cervical length Gestational age at delivery according to cervical length 1 year No
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