Von Willebrand Factor in Pregnancy (VIP) Study

Recruiting now

Conditions studied: Von Willebrand Diseases

In brief

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.

Key facts

Study ID

NCT04146376

Run by

University of Washington

People needed

110

Starts

2019-10-12

Expected to finish

2026-12-01

Last updated by the study team

2025-12-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• von Willebrand Disease (VWD) patients defined prepartum as Type 1 per National Heart, Lung, and Blood Institute (NHLBI) criterion of von Willebrand Factor (VWF) level less than 30 percent, or Type 2, or Type 3 VWD
• or
• A diagnosis of VWD and VWF and Factor VIII (FVIII) levels obtained in gestational weeks 34-38 that determine enrollment in the non-corrector group:
• Patients with gestational week 34-38 VWF:Ag, VWF:Act (or VWF:RCo), or FVIII:C less than 100 percent will be enrolled in the non-corrector group. In patients with an isolated VWF:CB type 2 defect, VWF:CB less than 100 percent can also be determined as a non-corrector
• Patients with all VWF parameter levels greater than or equal to 100 percent self-corrected at gestational weeks 34-38 will be enrolled in the corrector group
• Written informed consent from the patient prepartum, before gestational week 39

You may not qualify if…

• Presence of a clinical contraindication to receive wilate or tranexamic acid, as determined by the health care provider, such as a prior drug reaction
• Presence of other concurrent disorder of hemostasis, platelet dysfunction, or collagen disorders
• Presence of liver disease or renal disease, clinical suspicion or diagnosis of preeclampsia or eclampsia, HELLP syndrome, TTP, DIC, or other acquired vasculopathy or coagulopathy
• Age less than 18 years
• Inability of the local laboratory to monitor the VWF laboratory tests needed during the course of treatment to determine Wilate dosing adjustments

Where it is running

• Washington Center for Bleeding Disorders — Seattle, Washington, United States (enrolling)
• Yale University — New Haven, Connecticut, United States (enrolling)
• University of Miami — Miami, Florida, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• Bleeding & Clotting Disorders Institute — Peoria, Illinois, United States (enrolling)
• Tulane University School of Medicine, Louisiana Center for Bleeding and Clotting Disorders — New Orleans, Louisiana, United States (enrolling)
• University of Colorado — Aurora, Colorado, United States (enrolling)
• The Pennsylvania State University — Hershey, Pennsylvania, United States (enrolling)
• Vanderbilt University — Nashville, Tennessee, United States (enrolling)
• University of Utah — Salt Lake City, Utah, United States (enrolling)
• Oregon Health & Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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