Status:
ENROLLING_BY_INVITATION
Genomic Sequencing for Evaluation of Fetal Structural Anomalies
Lead Sponsor:
University of California, San Francisco
Conditions:
Fetal Structural Anomalies
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
This study follows an observational prospective cohort design. Women with fetal structural anomalies are routinely offered diagnostic testing with chorionic villus sampling or amniocentesis, with anal...
Detailed Description
Over the last several years, UCSF providers in the Fetal Treatment Center (FTC) and Prenatal Diagnosis Center (PDC) have been conducting genomic sequencing research studies for prenatal cases of fetal...
Eligibility Criteria
Inclusion
- Pregnant individual \>18 years of age
- Pregnant with a fetus (singleton or multiple gestation) affected by one or more fetal anomalies, unexplained fetal death after 14 wks, unexplained severe fetal growth restriction (\< 3%ile), unexplained severe polyhydramnios
Exclusion
- Declines diagnostic testing with karyotype or microarray
- Fetal anomaly explained by other testing (viral infection, aneuploidy or copy number variant detected by microarray)
Key Trial Info
Start Date :
September 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 15 2030
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06054230
Start Date
September 18 2023
End Date
July 15 2030
Last Update
April 6 2025
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143