Hemophilia A Research Program

Study Summary

This study longitudinally observes the intergenerational (mother-child) continuum in hemophilia A from pregnancy through early childhood. Because the study follows mother-child pairs, the study includes both a maternal cohort and a pediatric cohort. Each cohort has a primary goal: for the mother with a severe hemophilia genotype, the overarching primary goal is to understand the risks for pregnancy-associated bleeding and postpartum hemorrhage (PPH); for the child, the overarching primary goal is to understand the risks, timing, and circumstances of development of anti-FVIII antibodies. From a longitudinal perspective, risks for both bleeding in the mother and anti-FVIII antibody development in the child are expected to be influenced over time by genetic and environmental factors that begin early in (or before) pregnancy. Enrollment of blood relatives is offered to improve power to better understand inherited contributions to bleeding and inhibitor development in the mother-baby pairs.

Primary Outcome

The study primary endpoints/outcomes for the maternal and pediatric cohorts are as follows: • Maternal: Rates of primary PPH, defined as * estimated or quantified blood loss \> 1,000 mL in the first 24 hours PP, or * unplanned transfusion of blood products related to blood loss in the first 24 hours PP. As a subset of primary PPH, severe primary PPH is defined as * estimated or quantified blood loss \> 1,500 mL or requirement of \> 2 units packed red blood cells within 24 hours PP, or * prim

Conditions Studied

Study Locations (1)