Clinical Performance of NIPT in Multiple Gestation Pregnancies
Completed
- Conditions
- Trisomy 21 in Fetus
- Registration Number
- NCT04488393
- Lead Sponsor
- University of Pennsylvania
- Brief Summary
This study plans to evaluate the clinical performance of the MaterniT21 PLUS and/or GENOME Laboratory Developed Test, in the detection of fetal trisomy 21 in circulating cell-free DNA extracted from maternal blood samples obtained from women pregnant with a twin gestation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 2000
Inclusion Criteria
- subject pregnant with a multiple gestation and received NIPT from Sequenom Laboratories;
- subject was 18 or older at the time of NIPT
Exclusion Criteria
- none
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determination of sensitivity of NIPT detection of trisomy 21 among a population of women with twin gestations. time from maternal blood draw to delivery Determination of specificity of NIPT detection of trisomy 21 among a population of women with twin gestations. time from maternal blood draw to delivery
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Pennsylvania🇺🇸Philadelphia, Pennsylvania, United States