Von Willebrand Factor in Pregnancy (VIP) Study

This observational study, called the VIP Study, is looking at pregnant women with von Willebrand disease (VWD), a bleeding disorder. The study aims to understand how to best manage VWF levels during delivery to prevent heavy bleeding after birth (postpartum hemorrhage or PPH). You might be able to join if you have VWD, specifically Type 1 (with VWF levels less than 30%), Type 2, or Type 3, or if your VWF and Factor VIII (FVIII) levels are below 100% in your third trimester. The study will use Wilate, a VWF replacement therapy, to maintain specific VWF levels around delivery, and all participants will receive tranexamic acid to help prevent PPH. The main goal is to see how often PPH occurs within 24 hours after delivery.

Study design: This is an observational study that will follow up to 110 women with von Willebrand disease. It is an open-label cohort study, meaning both you and the study team will know which treatments you are receiving.
What's involved: You would use a postpartum diary to record information about bleeding, medication use (Wilate and tranexamic acid), and treatment schedules. You would also have several blood draws in addition to your routine clinical care.
Compensation: Not stated in the trial record.
Follow-up: The primary outcome of postpartum hemorrhage is measured within 24 hours postpartum. The study will also assess other effectiveness and safety outcomes, but the duration of follow-up is not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Von Willebrand Factor in Pregnancy (VIP) Study

Recruiting

Not specifiedAges 18+Observational

University of Washington

~110 participants

Updated 2025-12-18 on ClinicalTrials.gov

What's tested:Use of a postpartum diary and additional blood drawsVWF replacement therapy with WilateTranexamic acidUse of a postpartum diary and additional blood draws.

At a glance

Recruiting sites

10 of 11 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

rate of primary postpartum hemorrhage (PPH)

Measured over within 24 hours postpartum

Conditions

Von Willebrand Diseases

NCT04146376

Where you'd take part

This study runs at 11 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

Bleeding & Clotting Disorders Institute
Peoria, Illinoisstudy coordinator listed
Recruiting
Emory University
Atlanta, Georgiastudy coordinator listed
Recruiting
The Pennsylvania State University
Hershey, Pennsylvaniastudy coordinator listed
Recruiting
Tulane University School of Medicine, Louisiana Center for Bleeding and Clotting Disorders
New Orleans, Louisianastudy coordinator listed
Recruiting
University of Colorado
Aurora, Coloradostudy coordinator listed
Recruiting
University of Miami
Miami, Floridastudy coordinator listed
Recruiting
University of Utah
Salt Lake City, Utahstudy coordinator listed
Recruiting
Vanderbilt University
Nashville, Tennesseestudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Jill M Johnsen, M.D. · PRINCIPAL_INVESTIGATOR · University of Washington
Barbara A Konkle, M.D. · PRINCIPAL_INVESTIGATOR · Washington Center for Bleeding Disorders
Peter A Kouides, M.D. · PRINCIPAL_INVESTIGATOR · Mary M. Gooley Hemophilia Center

Who to contact

Central Study Contact

[email protected]

919-792-3740

Email the study team

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Eligibility criteria

Inclusion

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

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

Exclusion

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

What this trial measures

rate of primary postpartum hemorrhage (PPH)within 24 hours postpartum
defined as the estimated and/or quantified blood loss greater than or equal to 1000 mL within 24 hours postpartum; unplanned transfusion of blood products related to blood loss in the first 24 hours postpartum. As a subset of primary PPH, severe primary PPH is defined as the estimated and/or quantified blood loss greater than or equal to 1500 mL and/or requirement of greater than 2 units packed red blood cells within 24 hours postpartum; primary PPH greater than 1000 mL and evidence of maternal hemodynamic instability (tachycardia, hypotension) and/or end organ damage with no other etiology (oliguria, creatinine greater than 0.8, etc.)

Trialytics