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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women | Women with higher risk of FNAIT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical data collection | Other | Laboratory tests, Vital assessments, Maternal and fetal genotype testing, Antibodies Testing will be performed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with higher FNAIT risk characterized by race and ethnicity | At inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of anti-HPA-1a maternal alloimmunization | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant women presenting at a Gestation Week 10 to 14 pre-natal visit
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Horizons Clinical Trials, LLC | Chandler | Arizona | 85224 | United States | ||
| Zillan Clinical Research - Gardena |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 20, 2022 | Mar 4, 2026 |
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| 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 |
| Gardena |
| California |
| 90247 |
| United States |
| Yale University School of Medicine | New Haven | Connecticut | 06511 | United States |
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States |
| Cooper University Hospital | Camden | New Jersey | 08103 | United States |
| Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | United States |
| St. Peter's University Hospital | New Brunswick | New Jersey | 08901 | United States |
| Rutgers New Jersey Medical School | Newark | New Jersey | 07103 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
| New York-Presbyterian-Queens | New York | New York | 10065 | United States |
| Weill Cornell Medicine-New York Presbyterian Hospital | New York | New York | 10065 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| Wright State Physicians Obstetrics & Gynecology | Dayton | Ohio | 45409 | United States |
| Temple Perinatal Diagnosis Center | Philadelphia | Pennsylvania | 19140 | United States |
| Javara Inc. - Forest | Dallas | Texas | 75230 | United States |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| Javara Research Inc. - Dallas - PPDS | Houston | Texas | 77054 | United States |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Klinikum der Friedrich Schiller Universität Jena | Jena | Thuringia | 07747 | Germany |
| Leids Universitair Medisch Centrum | Leiden | South Holland | 2333 ZA | Netherlands |
| Oslo Universitetssykehus HF, Ullevål | Oslo | Oslo | 0524 | Norway |
| Universitetssykehuset Nord Norge | Tromsø | NO-9019 | Norway |
| Barnmorskestationen Rosengård | Lund | Skåne County | 222 42 | Sweden |
| Södersjukhuset | Stockholm | Stockholms Ian | 118 83 | Sweden |
| Clinical Trial Consultants - Uppsala | Uppsala | Uppsala Ian | 752 37 | Sweden |
| St. Thomas' Hospital | London | Surrey | SE1 7EH | United Kingdom |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 8, 2025 | Mar 4, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D054098 | Thrombocytopenia, Neonatal Alloimmune |
| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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