Feasibility Study of a New Screening Program for Major Aneuploidies (T21, T18, T13) in the Emilia-Romagna Region (SAPERER)
NCT ID: NCT04437992
Last Updated: 2020-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
7000 participants
OBSERVATIONAL
2020-01-27
2021-04-27
Brief Summary
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Currently, 14,400 combined tests are carried out in the Emilia Romagna Region every year.
As a result offering the new non-invasive NIPT test, it is estimated that the number of participants in the screening program will increase by up to 20,000/year.
The study will collect data on the women who will access the combined test in the first 9 months of the protocol and join the enrollment.
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Pregnant women
* Pregnant women resident in the Emilia Romagna region who access the combined test at regional counseling centers and hospital prenatal clinics.
* Women able to understand the information, participate in pre-test counseling and provide informed consent.
NIPT
The test, which requires two 10 ml tubes of blood, will be performed simultaneously with the chemical biomarkers of the combined test at 10-12 weeks of gestation
Interventions
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NIPT
The test, which requires two 10 ml tubes of blood, will be performed simultaneously with the chemical biomarkers of the combined test at 10-12 weeks of gestation
Eligibility Criteria
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Inclusion Criteria
* Women able to understand the information, participate in pre-test counseling and provide informed consent.
Exclusion Criteria
* pregnancies with more than two twins
* certain evidence of initial twinning, with subsequent disappearance of one of the twins (vanishing twin)
* known maternal chromosome mosaicisms present in the mother and involving the chromosomes subject to investigation
* presence of neoplasia in pregnant women
* previous allogeneic transplantation in pregnant women
* immunotherapy, radiotherapy or hemotransfusion performed in the pregnant woman within the previous 3 months.
18 Years
FEMALE
Yes
Sponsors
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Azienda Usl di Bologna
OTHER_GOV
Responsible Party
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Locations
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Regione Emilia Romagna
Bologna, , Italy
Countries
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Facility Contacts
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Other Identifiers
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SAPERER
Identifier Type: -
Identifier Source: org_study_id
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