Prevent Postpartum Hemorrhage in Women With Von Willebrand Disease: The VWD-WOMAN Trial
Status:
Recruiting
Trial end date:
2023-09-01
Target enrollment:
Participant gender:
Summary
This is a single-center randomized phase III clinical trial, the VWD-Woman Trial, in which 20
pregnant subjects with von Willebrand disease (VWD), defined as VWF ristocetin co-factor
activity (VWF:RCo) <0.50 IU/ml (historic) and previous history of bleeding are enrolled.
Subjects will include women with VWD age 18 years and older, excluding those who have a
bleeding disorder other than VWD. Once enrolled, subjects who meet all of the inclusion and
none of the exclusion criteria will be randomized to recombinant Von Willebrand factor (rVWF,
Vonvendi ®) with Tranexamic Acid (TA, Cyclokapron®); or recombinant Von Willebrand factor
(rVWF, Vonvendi®) alone to prevent postpartum hemorrhage after vaginal or caesarean delivery.
The primary endpoint is quantitative blood loss (QBL) by a labor suite nurse at delivery.
Secondary endpoints include safety assessment for postpartum lochial blood loss by Pictorial
Blood Assessment Chart (PBAC), transfusion, blood products, thromboembolic events, and
hysterectomy within 21 days; and mechanism of PPH reduction by VWF assays (VWF:RCo, VWF:Ag,
VIII:C), fibrinogen, and d-dimer. Blood draws are at 5 time points, including at 36 weeks'
gestation (screening), on admission for childbirth, and at 1 day, 2 days, and 21 days after
delivery. The VWD-Woman Trial is considered greater than minimal risk as study drugs are
given at delivery and special coagulation studies are obtained.