Cell- Based Noninvasive Prenatal Testing (NIPT): Single Cell Prenatal Diagnosis (SCPD) (NIPT & SCPD)

Luna Genetics

Status: Completed

Conditions: Pregnancy Related

Treatments: Diagnostic Test: Redraw for analysis of blood samples from healthy pregnant women

Study type: Interventional

Funder types: Industry

Identifiers

NCT05076734

Luna IRB LG-002

Details and patient eligibility

About

The purpose of the overall study is to develop improved methods for recovery of fetal cells from the mother's blood in order to develop a clinically useful form of cell-based, diagnostic, noninvasive prenatal testing (NIPT). Luna Genetics will analyze blood samples from healthy pregnant women. A phlebotomist will be sent to any location in the United States to collect the blood sample. Sample identifiers will be removed as the first step so that laboratory personnel will not see or have access to identifiers. No information will go back to patients or their physicians.

Enrollment: 157 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant
• 18years or older

Exclusion criteria

• Language barrier (non-English speaking and no adequate interpreter)
• Maternal age of less than 18 years
• Higher order multiple pregnancy (triplet or greater)
• Not currently pregnant

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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157 participants in 1 patient group

Analysis of blood samples from healthy pregnant women

Other group

Description:

A phlebotomist will be sent to any location in the United States to collect the blood sample. Sample identifiers will be removed as the first step so that laboratory personnel will not see or have access to identifiers. No information will go back to patients or their physicians.

Treatment:

Diagnostic Test: Redraw for analysis of blood samples from healthy pregnant women