Clinical Performance of NIPT in Multiple Gestation Pregnancies

Trisomy 21 in Fetus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04488393
• Other study ID #: SCMM-T21-110
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: June 19, 2022

Study information

• Verified date: December 2022
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: June 19, 2022
• Est. primary completion date: November 15, 2021
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Down Syndrome
• Trisomy 21 in Fetus

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Sequenom, Inc/Laboratory Corporation of America Holdings

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of sensitivity of NIPT detection of trisomy 21 among a population of women with twin gestations.		time from maternal blood draw to delivery
Primary	Determination of specificity of NIPT detection of trisomy 21 among a population of women with twin gestations.		time from maternal blood draw to delivery