Managing von Willebrand Disease in Pregnant Women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on pregnant women with von Willebrand disease (VWD) who have low von Willebrand factor (VWF) levels in the third trimester. It aims to determine the optimal VWF levels needed to minimize postpartum hemorrhage by using Wilate VWF replacement therapy to maintain VWF levels between 100-150% during delivery. Participants will be categorized into 'non-correctors' and 'correctors' based on their VWF levels, and outcomes will be assessed for both groups. The study also includes the use of tranexamic acid postpartum to further evaluate safety and effectiveness.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* von Willebrand Disease (VWD) patients defined prepartum as Type 1 per National Heart, Lung, and Blood Institute (NHLBI) criterion of von Willebrand Factor (VWF) level less than 30 percent, or Type 2, or Type 3 VWD

or

* A diagnosis of VWD and VWF and Factor VIII (FVIII) levels obtained in gestational weeks 34-38 that determine enrollment in the non-corrector group:
* Patients with gestational week 34-38 VWF:Ag, VWF:Act (or VWF:RCo), or FVIII:C less than 100 percent will be enrolled in the non-corrector group. In patients with an isolated VWF:CB type 2 defect, VWF:CB less than 100 percent can also be determined as a non-corrector
* Patients with all VWF parameter levels greater than or equal to 100 percent self-corrected at gestational weeks 34-38 will be enrolled in the corrector group

Written informed consent from the patient prepartum, before gestational week 39

Exclusion Criteria:

* Presence of a clinical contraindication to receive wilate or tranexamic acid, as determined by the health care provider, such as a prior drug reaction
* Presence of other concurrent disorder of hemostasis, platelet dysfunction, or collagen disorders
* Presence of liver disease or renal disease, clinical suspicion or diagnosis of preeclampsia or eclampsia, HELLP syndrome, TTP, DIC, or other acquired vasculopathy or coagulopathy
* Age less than 18 years
* Inability of the local laboratory to monitor the VWF laboratory tests needed during the course of treatment to determine Wilate dosing adjustments

Where it's running

• University of Colorado
  Aurora, Colorado, United States Recruiting
• Yale University
  New Haven, Connecticut, United States Recruiting
• University of Miami
  Miami, Florida, United States Recruiting
• Emory University
  Atlanta, Georgia, United States Recruiting
• Bleeding & Clotting Disorders Institute
  Peoria, Illinois, United States Recruiting
• Tulane University School of Medicine, Louisiana Center for Bleeding and Clotting Disorders
  New Orleans, Louisiana, United States Recruiting

Study contacts

• Principal investigator: Jill M Johnsen, M.D. — University of Washington
• Study coordinator: Central Study Contact
• Email: VIP.Study@ergomedgroup.com
• Phone: 919-792-3740

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.