NCT01367132CompletedNot Applicable
Assessment of the Number of Umbilical Cord Vessels at the Time of Nuchal Translucency Screening
Medstar Health Research Institute2 sites in 1 country123 target enrollmentStarted: February 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 123
- Locations
- 2
- Primary Endpoint
- Detection of the number of vessels in the umbilical cord between 11 and 13 6/7 weeks.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Detection of the number of vessels in the umbilical cord between 11 and 13 6/7 weeks.
Time Frame: 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
Secondary Outcomes
- 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)
Investigators
Study Sites (2)
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