Phase 3
Completed N=20
Prevent Postpartum Hemorrhage in Women With Von Willebrand Disease: The VWD-WOMAN Trial
Von Willebrand Diseases · postpartum hemorrhage
Source: ClinicalTrials.gov NCT04344860 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcomePrimary: Volume of Quantitative Blood Loss at Delivery — 727.0; 539.7 mL
◆ Published Evidence
Not yet cited
0citations
Impact of tranexamic acid on postpartum hemorrhage in type 1 von Willebrand disease treated with recombinant VWF.
Summary
This is a single-center randomized phase III clinical trial, the VWD-Woman Trial, in which 20 pregnant subjects with von Willebrand disease (VWD), defined as VWF ristocetin co-factor activity (VWF:RCo) <0.50 IU/ml (historic) and previous history of bleeding are enrolled. Subjects will include women with VWD age 18 years and older, excluding those who have a bleeding disorder other than VWD. Once enrolled, subjects who meet all of the inclusion and none of the exclusion criteria will be randomized to recombinant Von Willebrand factor (rVWF, Vonvendi ®) with Tranexamic Acid (TA, Cyclokapron®); or recombinant Von Willebrand factor (rVWF, Vonvendi®) alone to prevent postpartum hemorrhage after vaginal or caesarean delivery. The primary endpoint is quantitative blood loss (QBL) by a labor suite nurse at delivery. Secondary endpoints include safety assessment for postpartum lochial blood loss by Pictorial Blood Assessment Chart (PBAC), transfusion, blood products, thromboembolic events, and hysterectomy within 21 days; and mechanism of PPH reduction by VWF assays (VWF:RCo, VWF:Ag, VIII:C), fibrinogen, and d-dimer. Blood draws are at 5 time points, including at 36 weeks' gestation (screening), on admission for childbirth, and at 1 day, 2 days, and 21 days after delivery. The VWD-Woman Trial is considered greater than minimal risk as study drugs are given at delivery and special coagulation studies are obtained.
Linked Publications
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Impact of tranexamic acid on postpartum hemorrhage in type 1 von Willebrand disease treated with recombinant VWF.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Volume of Quantitative Blood Loss at Delivery |
727.0; 539.7 | — |
| SECONDARY Blood Loss Postpartum by Pictorial Bleeding Assessment Chart (PBAC) |
467.1; 344.8 | — |
| SECONDARY Number of Blood Products Used |
0; 0 | — |
| SECONDARY Concentration of Von Willebrand Factor |
1.89; 1.41; 2.20; 2.00; 3.3; 3.4 | — |
Eligibility Criteria
Inclusion Criteria
- Pregnant females >= 18 years of age
- Confirmed VWD, as defined by VWF:RCo < 0.50 IU/dL and previous history of bleeding
- Willingness to have blood drawn
- Willing to be randomized to one of two treatments at delivery and for 2 days postpartum.
- Willing to keep a diary for 3 weeks of postpartum bleeding by pictorial assessment chart (PBAC) and any blood products, transfusion, or medications taken.
- Willing to return at 21 days for final blood draw and review of diary.
Exclusion Criteria
- Any bleeding disorder other than VWD; or past thrombotic disease of other bleeding disorders.
- Previous thrombosis, cardiac disease, congestive failure, arrhythmia, hypertension, MI, or stroke.
- Platelet count < 100,000/ ul.
- Past allergic reaction to VWF or tranexamic acid.
- Surgery within the past 8 weeks.
- Inability to comply with study protocol requirements.
- Concomitant use of antiplatelet drugs, anticoagulants, or NSAIDs. Aspirin will be allowed for preeclampsia prevention.
- Treatment with DDAVP, cryoprecipitate, whole blood, plasma or plasma derivatives containing substantial quantities of VWF within 5 days of study.
- History of renal disease.
- Inability to comply with study requirements.
Data sourced from ClinicalTrials.gov (NCT04344860) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.