Assessment of the Number of Umbilical Cord Vessels at the Time of Nuchal Translucency Screening

February 20, 2013 updated by: Medstar Health Research Institute

The primary objective of this study is to determine the detection rate of two- or three-vessel umbilical cord at the time of nuchal translucency screening between 11 and 13 6/7 weeks gestation.

Hypothesis: Detection rate of the number of vessels during first trimester will be as accurate as the detection of vessels during the second trimester.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

123

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Hospital, MedStar Health
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center, MedStar Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing nuchal transluscency screening during 11-13+6 weeks gestation, followed by anatomy scan at 18-24 weeks gestation.

Description

Inclusion Criteria:

  • Singleton or multiple-gestation pregnancies in patients presenting for NT screening between 11 and 13 6/7 weeks gestation and CRL between 45-84mm as determined at the time of the ultrasound
  • Age 18 and older

Exclusion Criteria:

  • Patients who are incapable of informed consent or minors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Detection of the number of vessels in the umbilical cord between 11 and 13 6/7 weeks.
Time Frame: 11-13+6 weeks
11-13+6 weeks
Detection of the number of vessels in the umbilical cord between 18 and 23 6/7 weeks.
Time Frame: 18 - 23 6/7 weeks
18 - 23 6/7 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Sensitivity and specificity of transabdominal sonography at detecting vasculature of the cord between 11 and 13 6/7 weeks.
Time Frame: 11-13+6 weeks gestational age
11-13+6 weeks gestational age
Sensitivity and specificity of transabdominal sonography at detecting vasculature of the cord during the second trimester.
Time Frame: 18-24 weeks gestation
18-24 weeks gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medstar Health Research Institute

Investigators

  • Principal Investigator: Rita W Driggers, MD, Washington Hospital Center, MedStar Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

June 1, 2011

First Submitted That Met QC Criteria

June 3, 2011

First Posted (Estimate)

June 6, 2011

Study Record Updates

Last Update Posted (Estimate)

February 22, 2013

Last Update Submitted That Met QC Criteria

February 20, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MedStar 2010-450

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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