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RECRUITING
NCT04146376

Von Willebrand Factor in Pregnancy (VIP) Study

Sponsor: University of Washington

View on ClinicalTrials.gov

Summary

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.

Official title: Von Willebrand Factor in Pregnancy (VIP) Study: A Multicenter Study of Wilate Use in Von Willebrand Disease for Childbirth

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

110

Start Date

2019-10-12

Completion Date

2026-12

Last Updated

2025-12-18

Healthy Volunteers

No

Interventions

OTHER

Use of a postpartum diary and additional blood draws

A diary will be used to capture postpartum hemorrhage (PPH), Wilate and tranexamic acid use, other drug use, bleeding episodes, and treatment schedules. Several blood draws additional to what is expected for routine clinical care will also be taken.

DRUG

VWF replacement therapy with Wilate

This study design uses on-label Wilate for VWF replacement therapy for delivery and the postpartum period in VWD patients whose VWF levels are \<100% in the third trimester of pregnancy

DRUG

Tranexamic acid

This study design uses tranexamic acid for prophylaxis for postpartum hemorrhage for all women with VWD

OTHER

Use of a postpartum diary and additional blood draws.

A diary will be used to capture postpartum hemorrhage (PPH), tranexamic acid use, other drug use, bleeding episodes, and treatment schedules. Several blood draws additional to what is expected for routine clinical care will also be taken.

Locations (11)

University of Colorado

Aurora, Colorado, United States

Yale University

New Haven, Connecticut, United States

University of Miami

Miami, Florida, United States

Emory University

Atlanta, Georgia, United States

Bleeding & Clotting Disorders Institute

Peoria, Illinois, United States

Tulane University School of Medicine, Louisiana Center for Bleeding and Clotting Disorders

New Orleans, Louisiana, United States

Oregon Health & Science University

Portland, Oregon, United States

The Pennsylvania State University

Hershey, Pennsylvania, United States

Vanderbilt University

Nashville, Tennessee, United States

University of Utah

Salt Lake City, Utah, United States

Washington Center for Bleeding Disorders

Seattle, Washington, United States