Von Willebrand Factor in Pregnancy (VIP) Study

Conditions

• Von Willebrand Diseases

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Use of a postpartum diary and additional blood draws — OTHER
  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.
• VWF replacement therapy with Wilate — DRUG
  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
• Tranexamic acid — DRUG
  This study design uses tranexamic acid for prophylaxis for postpartum hemorrhage for all women with VWD
• Use of a postpartum diary and additional blood draws. — OTHER
  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.

Study Details

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.

Key Dates

Start date

Oct 12, 2019

Status verified

Dec 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

110 participants (estimated)

Arms

• Arm: Non-Corrector
  Patients with gestational week 34-38 von Willebrand factor activity, or von Willebrand factor ristocetin cofactor, or Factor VIII procoagulant activity less than 100 percent will be termed non-correctors. When laboratory monitoring can be performed, patients with an isolated von Willebrand factor collagen binding type 2 defect, von Willebrand factor collagen binding less than 100 percent can also be enrolled and determined as a non-corrector.
• Arm: Corrector
  Patients with von Willebrand factor parameter levels greater than or equal to 100 percent self-corrected at gestational weeks 34-38 will be termed correctors.

Primary Outcome Measure

rate of primary postpartum hemorrhage (PPH) [ Time Frame: within 24 hours postpartum ]

Central Contacts

• Central Study Contact
  919-792-3740
  [email protected]

Locations (11)

Find similar trials in Aurora, CO

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