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Von Willebrand Factor in Pregnancy (VIP) Study
NCT04146376 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DRUG Tranexamic acid
- OTHER Use of a postpartum diary and additional blood draws
- DRUG VWF replacement therapy with Wilate
- OTHER Use of a postpartum diary and additional blood draws.
Study Locations (11)
Colorado
- University of Colorado — Aurora
Connecticut
- Yale University — New Haven
Florida
- University of Miami — Miami
Georgia
- Emory University — Atlanta
Illinois
- Bleeding & Clotting Disorders Institute — Peoria
Louisiana
- Tulane University School of Medicine, Louisiana Center for Bleeding and Clotting Disorders — New Orleans
Oregon
- Oregon Health & Science University — Portland
Pennsylvania
- The Pennsylvania State University — Hershey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2019-10-12 |
| Est. Completion | 2026-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04146376
The ClinicalTrials.gov registry entry for NCT04146376 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 987 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Von Willebrand Diseases appearing as the primary indexed condition, and to 4 interventions — of which Tranexamic acid is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04146376 reports 11 study locations spanning 11 distinct geographic areas — top geographies include Colorado, Connecticut, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04146376 about?
NCT04146376 is a clinical study titled "Von Willebrand Factor in Pregnancy (VIP) Study". 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. Th...
What is the current status of trial NCT04146376?
This trial is currently recruiting. The enrollment target is 110 participants. The study started on 2019-10-12. Estimated completion is 2026-12.
What conditions does trial NCT04146376 study?
This clinical trial studies the following conditions: Von Willebrand Diseases. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04146376?
The interventions under investigation include: Tranexamic acid (DRUG), Use of a postpartum diary and additional blood draws (OTHER), VWF replacement therapy with Wilate (DRUG), Use of a postpartum diary and additional blood draws. (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04146376?
This trial is sponsored by University of Washington, which has 987 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04146376 being conducted?
This trial has 11 study locations across Colorado, Connecticut, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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