Clinical trial NCT01367132: Assessment of the Number of Umbilical Cord Vessels at the Time of Nuchal Translucency Screening
Official title: Assessment of the Number of Umbilical Cord Vessels at the Time of Nuchal Translucency Screening
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Umbilical Cord
Keywords: ultrasound
first trimester
umbilical cord
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2011-06-06
Enrollment: 123
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Detection of the number of vessels in the umbilical cord between 11 and 13 6/7 weeks.
timeFrame: 11-13+6 weeks
measure: Detection of the number of vessels in the umbilical cord between 18 and 23 6/7 weeks.
timeFrame: 18 - 23 6/7 weeks
Secondary outcomes:
measure: Sensitivity and specificity of transabdominal sonography at detecting vasculature of the cord between 11 and 13 6/7 weeks.
timeFrame: 11-13+6 weeks gestational age
measure: Sensitivity and specificity of transabdominal sonography at detecting vasculature of the cord during the second trimester.
timeFrame: 18-24 weeks gestation
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Hospital, MedStar Health
state: District of Columbia
city: Washington
country: United States
facility: Washington Hospital Center, MedStar Health
state: District of Columbia
Study officials:
affiliation: Washington Hospital Center, MedStar Health
name: Rita W Driggers, MD
role: PRINCIPAL_INVESTIGATOR
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