Study to Assess the Occurrence of HPA-1a Alloimmunization in Women With Higher Risk for Fetal and Neonatal Alloimmune Thrombocytopenia
- Conditions
- Fetal and Neonatal Alloimmune Thrombocytopenia
- Registration Number
- NCT05345561
- Lead Sponsor
- Rallybio
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 30000
- Pregnant women (≥ 18 years of age) who have provided informed consent for the study.
- Participants with prior history of FNAIT
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants with higher FNAIT risk characterized by race and ethnicity At inclusion
- Secondary Outcome Measures
Name Time Method Pregnancy outcomes: incidence of live births, spontaneous abortion, elective abortion, still birth, and premature birth At Week 10 postpartum or 10 weeks from the date of pregnancy terminating event Frequency of anti-HPA-1a maternal alloimmunization At Week 10 postpartum or 10 weeks from the date of pregnancy terminating event Occurrence of neonatal thrombocytopenia At birth or at the time of the pregnancy terminating event
Trial Locations
- Locations (28)
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
Scroll for more (18 remaining)New Horizons Clinical Trials, LLC🇺🇸Chandler, Arizona, United States