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Effect of Maternal BMI on Measurement of Cervical Length

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01882738
Recruitment Status : Unknown
Verified June 2013 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 20, 2013
Last Update Posted : June 20, 2013
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease
PREGNANCY

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).

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Maternal BMI on Accuracy of Measurement of Cervical Length During the 3rd Trimester of Pregnancy
Study Start Date : July 2013
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : July 2015



Primary Outcome Measures :
  1. Accuracy of cervical length according to BMI [ Time Frame: 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 :
  1. Gestational age at delivery according to cervical length [ Time Frame: 1 year ]
    Gestational age at delivery according to cervical length



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All pregnant women in 2nd or 3rd trimester who attend routine ultrasound exam
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Known shore cervix
  • PPROM

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01882738


Contacts
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Contact: Alon Shrim, MD +972-50-6246988 alon.shrim@gmail.com
Contact: Ron Belosseski, MD +972-50-9205759 Tomor2304@yahoo.com

Locations
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Israel
Hillel Yaffe Medical Center
Hadera, Israel
Contact: Alon Shrim, MD    +972-50-6246988    alon.shrim@gmail.com   
Contact: Ron Belosseski, MD    +972-50-6246988    TOMOR2304@YAHOO.COM   
Principal Investigator: Alon Shrim, MD         
Sponsors and Collaborators
Hillel Yaffe Medical Center
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Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01882738    
Other Study ID Numbers: 0039-13-HYMC
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: June 20, 2013
Last Verified: June 2013
Keywords provided by Hillel Yaffe Medical Center:
Cervical length
BMI