Cell-based Non-invasive Prenatal Test Workflow
ConditionPregnant Women
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMenarini Silicon Biosystems
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Unable to provide informed consent
Known infections that carry a risk of vertical transmission
Known maternal viral diseases: HIV and HCV, HBV
Trial population
Samples of peripheral blood (30 ml) will be collected from pregnant women at 8+0 - 14+6 weeks of gestation.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Blood collection
Other interventionSamples of peripheral blood (30 ml) will be collected from pregnant women
Treatment groups
1,400 Participants
are divided into 1 treatment groupGroup A: Pregnant women1 intervention
Trial outcomes
Primary outcomes
1
cEVTs isolation rate
To achieve a minimum recovery of 3 single fetal cells in at least 95% of 30mL maternal blood samples
Time frame
24 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: