Actively Recruiting
Von Willebrand Factor in Pregnancy (VIP) Study
Led by University of Washington · Updated on 2025-12-18
110
Participants Needed
11
Research Sites
372 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
E
Ergomed
Collaborating Sponsor
AI-Summary
What this Trial Is About
In pregnant women with von Willebrand disease (VWD) who by the third trimester do not have von Willebrand factor (VWF) or factor VIII (FVIII) levels greater than 50-100%, specific guidance is lacking for delivery planning in terms of how high of a VWF level should be achieved to reduce bleeding. This is a prospective, open-label, cohort study in women with VWD using Wilate VWF replacement therapy to maintain trough or minimum VWF levels of 100-150% for delivery and the immediate postpartum period, followed by levels of 50-100% for 5-10 days after delivery, depending upon the route of delivery. The primary objective is to document the rate of primary postpartum hemorrhage (PPH). The secondary objective is to document further effectiveness outcomes and safety.
CONDITIONS
Official Title
Von Willebrand Factor in Pregnancy (VIP) Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of von Willebrand Disease (VWD) Type 1, Type 2, or Type 3
- VWF and Factor VIII levels measured at gestational weeks 34-38
- Patients with VWF or FVIII levels less than 100% in weeks 34-38 enrolled in the non-corrector group
- Patients with all VWF parameters above or equal to 100% in weeks 34-38 enrolled in the corrector group
- Written informed consent given before gestational week 39
- Female participants aged 18 years or older
You will not qualify if you...
- Clinical contraindication to Wilate or tranexamic acid, such as prior drug reaction
- Other bleeding or clotting disorders like platelet dysfunction or collagen disorders
- Presence of liver disease, kidney disease, preeclampsia, eclampsia, HELLP syndrome, TTP, DIC, or other acquired vasculopathy or coagulopathy
- Age under 18 years
- Local laboratory unable to monitor required VWF tests for Wilate dosing
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 11 locations
1
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Yale University
New Haven, Connecticut, United States, 06510
Actively Recruiting
3
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
4
Emory University
Atlanta, Georgia, United States, 30308
Actively Recruiting
5
Bleeding & Clotting Disorders Institute
Peoria, Illinois, United States, 61615
Actively Recruiting
6
Tulane University School of Medicine, Louisiana Center for Bleeding and Clotting Disorders
New Orleans, Louisiana, United States, 70112
Actively Recruiting
7
Oregon Health & Science University
Portland, Oregon, United States, 97239
Withdrawn
8
The Pennsylvania State University
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
9
Vanderbilt University
Nashville, Tennessee, United States, 27232
Actively Recruiting
10
University of Utah
Salt Lake City, Utah, United States, 84108
Actively Recruiting
11
Washington Center for Bleeding Disorders
Seattle, Washington, United States, 98104
Actively Recruiting
Research Team
C
Central Study Contact
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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