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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04935138

Enrollment

Registered

2021-06-22

Start date

2021-06-01

Completion date

2022-12-31

Last updated

2023-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Pregnancy Loss

Brief summary

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.

Interventions

GENETICcfDNA analysis

sequencing data from cfDNA analysis

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame	Description
microarray analysis of products of conception (POC)	7 days	chromosome anomalies

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026