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

Quest Diagnostics-Nichols Insitute78 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Early Pregnancy Loss

Interventions

cfDNA analysisGENETIC

sequencing data from cfDNA analysis

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Quest Diagnostics

San Juan Capistrano, California, United States

Outcomes

Primary Outcomes

microarray analysis of products of conception (POC)

chromosome anomalies

Time frame: 7 days

Data from ClinicalTrials.gov

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