Clinical Performance of NIPT in Multiple Gestation Pregnancies

Clinical Performance of NIPT (Noninvasive Prenatal Testing) in Multiple Gestation Pregnancies (SCMM-T21-110)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04488393

Enrollment

2000

Registered

2020-07-28

Start date

2020-03-01

Completion date

2022-06-19

Last updated

2022-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trisomy 21 in Fetus

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.

Interventions

DEVICEMaterniT21 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.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026