A new multi-site study will measure postpartum von Willebrand factor (VWF) levels in women with von Willebrand disease (VWD) to provide clinical data for physicians who, until now, have had to rely on anecdotal evidence. Andra James, MD, Duke University Medical Center in Durham, NC, is the principal investigator of the study. Other sites that will participate include the Mary M. Gooley Hemophilia Center in Rochester, NY, and the Robert Wood Johnson University Hospital in New Brunswick, NJ. Two additional locations will be added later. James and her colleagues will assess how VWF levels fluctuate during the postpartum period and whether decreases in these levels can be linked to hemorrhaging.
Virtually all women experience a rise in their VWF and factor VIII (FVIII) levels during the third trimester of pregnancy. However, within one month postpartum there can be a gradual decrease to baseline levels. According to investigators, this situation contrasts significantly among women with VWD who may experience precariously low drops in their VWF and FVIII levels–-below the baseline-–during the postpartum phase. While this condition seemingly exposes VWD women to a significantly greater risk for excessive bleeding, the evidence until now has been mostly anecdotal.
The prospective cohort study is designed to compare changes in blood levels of VWF postpartum in an equal number of women with and without VWD. Tests to determine patients’ VWF levels will be conducted at periodic intervals in the immediate postpartum period. Investigators will assess how quickly, to what levels, and for how long VWF levels drop in the days post delivery. The data will help establish optimal clinical protocols.
“While we know that decreasing VWF levels following childbirth can result in serious complications for women with VWD, there are very little clinical data available to guide physicians in treating these patients,” said Peter Kouides, MD, a principal investigator of the study. He is the Medical and Research Director of the Mary M. Gooley Hemophilia Center. “By studying the patterns in declining VWF levels, we hope to learn whether treatment following birth is needed and the optimum duration of therapy.”
The study is being funded through a $1.2 million grant provided by CSL Behring.