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OpenTrials
Completed

NCT Number: NCT01367132

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

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.

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Key information

Conditions

Umbilical Cord

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Georgetown University Hospital, MedStar Health, Washington D.C., District of Columbia, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doppler ultrasound

Procedure

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

Primary outcomes

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

    Time frame: 11-13+6 weeks

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

    Time frame: 18 - 23 6/7 weeks

Secondary outcomes

  1. 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

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

    Time frame: 18-24 weeks gestation

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 6, 2011
Registry last updated
Feb 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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