Study of Wilate for Managing Von Willebrand Disease in Pregnant Women During and After Childbirth

What this Trial Is About

This research aims to better understand delivery planning for pregnant women with von Willebrand disease VWD who do not naturally have high enough levels of von Willebrand factor VWF or factor VIII FVIII by the third trimester. The study investigates whether maintaining higher VWF levels with replacement therapy can reduce bleeding risks during and after childbirth. It is a prospective, open-label, cohort study focusing on women with VWD and seeks to document the rate of primary postpartum hemorrhage and other safety outcomes. Participants are divided into two groups based on their natural VWF levels late in pregnancy non-correctors with levels below 100% receive Wilate VWF replacement therapy to maintain trough levels of 100-150% at delivery and during the immediate postpartum period, then 50-100% for 5-10 days after delivery depending on the delivery method. Correctors with natural VWF levels above 100% do not receive replacement therapy. All participants receive tranexamic acid for 14 days after delivery. The study includes use of postpartum diaries to record bleeding and treatment use, along with additional blood draws. During the study, women will be monitored through blood tests to track VWF and FVIII levels and assess bleeding outcomes. Researchers will evaluate rates of primary and secondary postpartum hemorrhage, along with other laboratory safety measures. The study collects detailed data from gestational weeks 34-38 through delivery and postpartum, supporting careful assessment of treatment effects and safety. Participation continues through the postpartum period, with diaries and monitoring to capture bleeding events and treatment adherence.

Von Willebrand Factor in Pregnancy (VIP) Study