Clinical Performance of NIPT in Multiple Gestation Pregnancies

Completed

• Conditions: Trisomy 21 in Fetus
• Interventions: Device: MaterniT21 PLUS and GENOME Laboratory-Developed Tests

• 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-07-22
• Study First Posted: 2020-07-28
• Primary Completion: 2021-11-15
• Study Completion: 2022-06-19
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-05
• Last Update Posted: 2022-12-07

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

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Exclusion Criteria

• none

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnancies with multiple gestations	MaterniT21 PLUS and GENOME Laboratory-Developed Tests	-

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

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States