Status:
COMPLETED
First Trimester Risk Assessment Based on Ultrasound and Cell-free DNA vs Combined Screening
Lead Sponsor:
Federico II University
Conditions:
Aneuploidy
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
There is an ongoing debate regarding how cell-free DNA (cfDNA) screening can best be incorporated into current prenatal screening algorithms for chromosomal abnormalities. Test performance of cfDNA h...
Eligibility Criteria
Inclusion
- Pregnant women with singleton gestations
- ≤12 6/7 weeks of gestation
- Normal ultrasound examination at the time of randomization
- \>18 \<45 years
- Crown-rump length (CRL) \<84 mm at the time of randomization
Exclusion
- Multiple gestations, including vanishing twins
- \>12 6/7 weeks of gestation
- Ectopic pregnancy
- Abnormal ultrasound examination at the time of first prenatal visit
- Women who are unconscious, severly ill, mentally handicapped, or under the age of 18 years.
- Women who have already planned for invasive prenatal testing, e.g. for a history of prior child or pregnancy with chromosomal or genetic abnormalities
- CRL \>84mm at the time of randomization
Key Trial Info
Start Date :
August 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04077060
Start Date
August 26 2019
End Date
February 15 2020
Last Update
February 24 2020
Active Locations (1)
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1
Gabriele Saccone
Napoli, Italy, 80129