๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-12-10

Von Willebrand Factor in Pregnancy (VIP) Study (NCT04146376)

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

๐ŸŸข Recruiting Interventional Protocol ๐Ÿ“Š Observational Clinical Research Sponsor: University of Washington

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: University of Colorado โ€” Aurora, Colorado

Age range: 18 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (11 Sites)

  • University of Colorado โ€” Aurora, Colorado
  • Yale University โ€” New Haven, Connecticut
  • University of Miami โ€” Miami, Florida
  • Emory University โ€” Atlanta, Georgia
  • Bleeding & Clotting Disorders Institute โ€” Peoria, Illinois
  • Tulane University School of Medicine, Louisiana Center for Bleeding and Clotting Disorders โ€” New Orleans, Louisiana
  • Oregon Health & Science University โ€” Portland, Oregon
  • The Pennsylvania State University โ€” Hershey, Pennsylvania
  • Vanderbilt University โ€” Nashville, Tennessee
  • University of Utah โ€” Salt Lake City, Utah
  • Washington Center for Bleeding Disorders โ€” Seattle, Washington

๐Ÿ“ž Contact the Study Coordinator

Phone: (919) 792-3740

Email: VIP.Study@ergomedgroup.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—