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Clinical Performance of NIPT in Multiple Gestation Pregnancies

NCT04488393 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2022-12-07

No results posted yet for this study

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.

Conditions

  • Trisomy 21 in Fetus

Interventions

DEVICE

MaterniT21 PLUS and GENOME Laboratory-Developed Tests

Both the MaterniT21 PLUS and GENOME are intended for use as laboratory developed test that analyze ccfDNA extracted from a maternal blood sample utilizing Massively Parallel Sequencing (MPS) technology.

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2021-11-15
Completion
2022-06-19

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04488393 on ClinicalTrials.gov