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Von Willebrand Factor in Pregnancy (VIP) Study

NCT04146376 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 110

Last updated 2025-12-18

No results posted yet for this study

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.

Conditions

  • Von Willebrand Diseases

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.

Sponsors & Collaborators

Principal Investigators

  • Jill M Johnsen, M.D. · University of Washington

  • Barbara A Konkle, M.D. · Washington Center for Bleeding Disorders

  • Peter A Kouides, M.D. · Mary M. Gooley Hemophilia Center

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-12
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04146376 on ClinicalTrials.gov