Effect of Maternal BMI on Measurement of Cervical Length

• Conditions: PREGNANCY

• Registration Number: NCT01882738
• Lead Sponsor: Hillel Yaffe Medical Center

Brief 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

Detailed 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).

Study Timeline

• Status Verified: 2013-06
• Study First Submitted: 2013-06-11
• Study First Submitted QC: 2013-06-18
• Last Update Submitted: 2013-06-18
• Study First Posted: 2013-06-20
• Last Update Posted: 2013-06-20
• Study Start: 2013-07
• Primary Completion: 2014-07
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

• Known shore cervix
• PPROM

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of cervical length according to BMI	1 year	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

Secondary Outcome Measures

Name	Time	Method
Gestational age at delivery according to cervical length	1 year	Gestational age at delivery according to cervical length

Trial Locations

Locations (1)

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel