Fetal and Neonatal Alloimmune Thrombocytopenia
Conditions
Keywords
Alloimmunization, HPA-1a, Fetal and Neonatal Alloimmune Thrombocytopenia, Neonatal thrombocytopenia, Pregnant women
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.
Interventions
Laboratory tests, Vital assessments, Maternal and fetal genotype testing, Antibodies Testing will be performed.
Sponsors
Rallybio
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women (≥ 18 years of age) who have provided informed consent for the study.
Exclusion criteria
* Participants with prior history of FNAIT
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with higher FNAIT risk characterized by race and ethnicity | At inclusion |
Secondary
| Measure | 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 | 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 |
Countries
Canada, Germany, Netherlands, Norway, Sweden, United Kingdom, United States
Outcome results
None listed