Von Willebrand Factor in Pregnancy (VIP) Study

Description

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

Von Willebrand Diseases

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Study Overview

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Study Details

Study overview

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.

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

Von Willebrand Factor in Pregnancy (VIP) Study

Condition
Von Willebrand Diseases
Intervention / Treatment

-

Contacts and Locations

Aurora

University of Colorado, Aurora, Colorado, United States, 80045

New Haven

Yale University, New Haven, Connecticut, United States, 06510

Miami

University of Miami, Miami, Florida, United States, 33136

Atlanta

Emory University, Atlanta, Georgia, United States, 30308

Peoria

Bleeding & Clotting Disorders Institute, Peoria, Illinois, United States, 61615

New Orleans

Tulane University School of Medicine, Louisiana Center for Bleeding and Clotting Disorders, New Orleans, Louisiana, United States, 70112

Portland

Oregon Health & Science University, Portland, Oregon, United States, 97239

Hershey

The Pennsylvania State University, Hershey, Pennsylvania, United States, 17033

Nashville

Vanderbilt University, Nashville, Tennessee, United States, 27232

Salt Lake City

University of Utah, Salt Lake City, Utah, United States, 84108

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Washington,

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

Study Record Dates

2026-12