RecruitingNCT04146376

Von Willebrand Factor in Pregnancy (VIP) Study

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


Sponsor

University of Washington

Enrollment

110 participants

Start Date

Oct 12, 2019

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study, called the VIP (Von Willebrand Factor in Pregnancy) Study, is looking at how Von Willebrand Disease (VWD) — a common inherited bleeding disorder — affects women during and after pregnancy. VWD causes problems with blood clotting, which can lead to serious bleeding around the time of childbirth. Normally, pregnancy causes VWF levels to rise and may temporarily correct the disorder, but not all women with VWD experience this correction. The study is tracking pregnant women with VWD to better understand their bleeding risk during delivery and the postpartum period. Women are divided into two groups: those whose VWD naturally corrects during pregnancy, and those whose VWD does not correct. The researchers want to learn how best to prevent and manage serious bleeding in these women. You may be eligible if: - You are a woman diagnosed with Type 1, Type 2, or Type 3 Von Willebrand Disease - You are pregnant and can provide consent before week 39 of pregnancy - Your VWF and Factor VIII levels have been measured between gestational weeks 34–38 You may NOT be eligible if: - You have a known contraindication to the study medications (wilate or tranexamic acid) - You have another bleeding disorder, platelet dysfunction, or collagen disorder - You have liver disease, kidney disease, preeclampsia, HELLP syndrome, or other clotting disorders - You are under 18 years of age - Your local lab cannot perform the required VWF monitoring tests Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERUse 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.

DRUGVWF 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

DRUGTranexamic acid

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

OTHERUse 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

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NCT04146376


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