Postpartum von Willebrand factor levels in women with and without von Willebrand disease and implications for prophylaxis.
A H James, B A Konkle, P Kouides...
https://pubmed.ncbi.nlm.nih.gov/25333737Actively Recruiting
Age: 18Years +
FEMALE
ID04146376
Von Willebrand Factor in Pregnancy (VIP) Study: A Multicenter Study of Wilate Use in Von Willebrand Disease for Childbirth
Led by University of Washington · Updated on 2025-12-18
110
Participants Needed
11
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
E
Ergomed
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Von Willebrand Factor in Pregnancy (VIP) Study
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Women diagnosed with von Willebrand Disease (Type 1, 2, or 3) or diagnosed with VWD and specific VWF and Factor VIII levels during pregnancy
- Patients with gestational week 34-38 VWF:Ag, VWF:Act (or VWF:RCo), or FVIII:C less than 100% (non-corrector group)
- Patients with isolated VWF:CB type 2 defect with VWF:CB less than 100% can be included
- Patients with all VWF parameter levels greater than or equal to 100% at gestational weeks 34-38 (corrector group)
- Written informed consent given before 39 weeks of pregnancy
- Female gender
- Age 18 years or older
You will not qualify if you...
- Clinical contraindication to receive Wilate or tranexamic acid, such as prior drug reaction
- Other bleeding or clotting disorders, platelet dysfunction, or collagen disorders
- Liver or kidney disease, or clinical suspicion or diagnosis of preeclampsia, eclampsia, HELLP syndrome, TTP, DIC, or other vasculopathy or coagulopathy
- Age under 18 years
- Inability of local laboratory to monitor required VWF tests for Wilate dosing adjustments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - From third trimester (gestational week 34-38) through 14 days postpartum
Participants in the non-corrector group receive von Willebrand factor (VWF) replacement therapy with Wilate to maintain specific VWF levels for delivery, and all participants receive tranexamic acid for 14 days postpartum. A postpartum diary and additional blood draws are used to monitor postpartum hemorrhage, bleeding episodes, and treatment schedules.
Visits as needed for monitoring and treatment during delivery and postpartum period
Long-term Monitoring
Duration - Up to 6 weeks postpartum
Participants are observed for secondary postpartum hemorrhage and safety outcomes for up to 6 weeks postpartum, with ongoing use of postpartum diaries and additional blood draws.
Follow-up visits up to 6 weeks postpartum
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
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Research Team
C
Central Study 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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Published Research Related To This Trial
Complex changes in von Willebrand factor-associated parameters are acquired during uncomplicated pregnancy.
Danielle N Drury-Stewart, Kerry W Lannert, Dominic W Chung...
https://pubmed.ncbi.nlm.nih.gov/25409031Present day management of inherited bleeding disorders in pregnancy.
Peter A Kouides
https://pubmed.ncbi.nlm.nih.gov/27459638Pregnancy and laboratory studies: a reference table for clinicians.
Mina Abbassi-Ghanavati, Laura G Greer, F Gary Cunningham
https://pubmed.ncbi.nlm.nih.gov/19935037Haemostatic reference intervals in pregnancy.
Pal B Szecsi, Maja Jørgensen, Anna Klajnbard...
https://pubmed.ncbi.nlm.nih.gov/20174768Changes in the levels of factor VIII and von Willebrand factor in the puerperium.
F Y Huq, A Kulkarni, E C Agbim...
https://pubmed.ncbi.nlm.nih.gov/21951573von Willebrand disease (VWD): evidence-based diagnosis and management guidelines, the National Heart, Lung, and Blood Institute (NHLBI) Expert Panel report (USA).
W L Nichols, M B Hultin, A H James...
https://pubmed.ncbi.nlm.nih.gov/18315614Gynaecological and obstetric management of women with inherited bleeding disorders.
Christine Demers, Christine Derzko, Michèle David...
https://pubmed.ncbi.nlm.nih.gov/16100628Evidence-based recommendations on the treatment of von Willebrand disease in Italy.
Pier Mannuccio Mannucci, Massimo Franchini, Giancarlo Castaman...
https://pubmed.ncbi.nlm.nih.gov/19503633The diagnosis and management of von Willebrand disease: a United Kingdom Haemophilia Centre Doctors Organization guideline approved by the British Committee for Standards in Haematology.
Mike A Laffan, Will Lester, James S O'Donnell...
https://pubmed.ncbi.nlm.nih.gov/25113304