A prospective, non-interventional, natural history study to assess the occurrence of higher FNAIT risk across a broad population of different racial and ethnic characteristics and the occurrence of HPA-1a alloimmunization in these women.
Study Type
OBSERVATIONAL
Enrollment
14,390
Laboratory tests, Vital assessments, Maternal and fetal genotype testing, Antibodies Testing will be performed.
Number of participants with higher FNAIT risk characterized by race and ethnicity
Time frame: At inclusion
Frequency of anti-HPA-1a maternal alloimmunization
Time frame: At Week 10 postpartum or 10 weeks from the date of pregnancy terminating event
Pregnancy outcomes: incidence of live births, spontaneous abortion, elective abortion, still birth, and premature birth
Time frame: At Week 10 postpartum or 10 weeks from the date of pregnancy terminating event
Occurrence of neonatal thrombocytopenia
Time frame: At birth or at the time of the pregnancy terminating event
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New Horizons Clinical Trials, LLC
Chandler, Arizona, United States
Zillan Clinical Research - Gardena
Gardena, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Cooper University Hospital
Camden, New Jersey, United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
St. Peter's University Hospital
New Brunswick, New Jersey, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University Irving Medical Center
New York, New York, United States
...and 18 more locations