Fetal Cell Analysis From Maternal Blood

Menarini

Status: Enrolling

Conditions: Genetic Disease; Pregnancy Related; Prenatal Screening

Treatments: Other: Cell-based non-invasive prenatal testing

Study type: Interventional

Funder types: Industry

Identifiers

NCT05671744

MBS21-CBNIPD-001

Details and patient eligibility

About

The aim of this clinical study is the evaluation of clinical performance of a cell-based non-invasive test technology for fetal aneuploidies and segmental imbalances detection in a high-risk pregnancies population.

Enrollment: 1,500 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant has a viable singleton or twin pregnancy
• Women who have already been selected by their treating physician to undergo an invasive fetal diagnostic procedure
• Participant is at least 18 years old and can provide informed consent

Exclusion criteria

• Unable to provide informed consent
• Prenatal diagnosis of clinical Chorioamnionitis
• Intake of drugs or exposure to teratogenic agents
• Infections that carry a risk of vertical transmission
• Known maternal viral diseases: HIV and HCV, HBV

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,500 participants in 1 patient group

Blood samples from pregnant women

Other group

Description:

Samples of peripheral blood collected from pregnant women undergoing CVS or genetic amniocentesis

Treatment:

Other: Cell-based non-invasive prenatal testing