Cell-free DNA Analysis of Chromosome Anomalies in Early Pregnancy Loss

Quest Diagnostics

Status: Terminated

Conditions: Early Pregnancy Loss

Treatments: Genetic: cfDNA analysis

Study type: Observational

Funder types: Industry

Identifiers

NCT04935138

CD20-011

Details and patient eligibility

About

The study assesses the accuracy of cell-free DNA (cfDNA) analysis in detecting whole chromosomal aneuploidies from maternal plasma of patients with early, missed miscarriage.

Enrollment: 78 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 5-20 weeks of gestation by ultrasound
• Miscarriage diagnosed by ultrasound
• Pregnancy tissue still present in utero, including an empty sac, and not completely expelled

Exclusion criteria

• Maternal age < 18 years
• No visible pregnancy tissue on ultrasound
• Multiple fetal gestation (> than singleton)
• Pregnancy was conceived using in vitro fertilization (IVF) with preimplantation genetic testing for aneuploidy (PGT-A) performed on the transferred embryo
• No microarray testing is planned on the product of conception
• Previous normal non-invasive prenatal testing (NIPT) or diagnostic testing (chorionic villous sampling or amniocentesis) in the current pregnancy
• Patient unable to provide consent