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

NCT01367132 | Completed

• 1 other identifier: MedStar 2010-450
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Umbilical Cord

Keywords

ultrasound; first trimester; umbilical cord

Outcome Measures

Primary Outcomes (2)

• Detection of the number of vessels in the umbilical cord between 11 and 13 6/7 weeks.

  11-13+6 weeks

• Detection of the number of vessels in the umbilical cord between 18 and 23 6/7 weeks.

  18 - 23 6/7 weeks

Secondary Outcomes (2)

• Sensitivity and specificity of transabdominal sonography at detecting vasculature of the cord between 11 and 13 6/7 weeks.

  11-13+6 weeks gestational age

• Sensitivity and specificity of transabdominal sonography at detecting vasculature of the cord during the second trimester.

  18-24 weeks gestation

Interventions

Doppler ultrasound PROCEDURE

Ultrasound using Doppler mode to detect blood flow in umbilical cord vasculature and determine the number of vessels present

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients who are incapable of informed consent or minors

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (2)

Georgetown University Hospital, MedStar Health

Washington D.C., District of Columbia, 20007, United States

Location

Washington Hospital Center, MedStar Health

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (20)

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  PMID: 11392597 BACKGROUND

Study Officials

• Rita W Driggers, MD

  Washington Hospital Center, MedStar Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2011
• First Posted: June 6, 2011
• Study Start: February 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: February 22, 2013

Record last verified: 2013-02

Locations

US (2)