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Not yet recruiting NCT07566780

Cell-based Non-invasive Prenatal Test Workflow

— Observational Pregnant Women

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood collection.
Who it may be relevant to
Registry conditions: Pregnant Women. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prospective Collection of Maternal Venous Blood Samples for Cell-based Non- Invasive Prenatal Test Workflow

Overview

The aim of this study is to optimize a new non-invasive prenatal screening method based on the capture of fetal cells from maternal blood and to complete its development by obtaining maternal blood samples during the first trimester of pregnancy.

Interventions

  • Other Blood collection
    Samples of peripheral blood (30 ml) will be collected from pregnant women

Primary outcome measures

  • cEVTs isolation rate [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

  • Informed consent signed before any study-specific procedures
  • Pregnant women with singleton or twin pregnancy, at 8+0 - 14+6 week of gestation, aged ≥18 years
  • No medical contraindication for collecting 30 ml blood sample

Exclusion criteria

  • Unable to provide informed consent
  • Known infections that carry a risk of vertical transmission
  • Known maternal viral diseases: HIV and HCV, HBV

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07566780 · MSB25-CBNIPT-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗