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NCT04344860 · ClinicalTrials.gov registry record · Phase 3
Prevent Postpartum Hemorrhage in Women With Von Willebrand Disease: The VWD-WOMAN Trial
A Phase 3 study, sponsored by Nicoletta C Machin.
- Completed
- Registry status
- Phase 3
- Development phase
- 20
- Enrollment target
NCT04344860: Completed Phase 3 study, sponsored by Nicoletta C Machin.
NCT04344860 is a Phase 3 study that has completed, run by Nicoletta C Machin. The registered enrollment target is 20 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04344860, a Phase 3 study, has completed, sponsored by Nicoletta C Machin.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 20 participants
- Enrollment target
Study 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.
Primary Outcome
Blood loss at delivery by standard QBL measured for 6 hours postpartum by the labor and delivery nursing staff.
Interventions
- DRUG Recombinant Von Willebrand factor
- DRUG Tranexamic Acid Injection [Cyklokapron]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-06-04 |
| Est. Completion | 2024-09-01 |
| Phase | Phase 3 |
What the finished NCT04344860 record still lists
NCT04344860 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Recombinant Von Willebrand factor is the first listed.
NCT04344860 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04344860 about?
NCT04344860 is a clinical study titled "Prevent Postpartum Hemorrhage in Women With Von Willebrand Disease: The VWD-WOMAN Trial". 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...
What is the current status of trial NCT04344860?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 20 participants. The study started on 2021-06-04. Estimated completion is 2024-09-01.
What interventions are being tested in trial NCT04344860?
The interventions under investigation include: Recombinant Von Willebrand factor (DRUG), Tranexamic Acid Injection [Cyklokapron] (DRUG).
Who is sponsoring clinical trial NCT04344860?
This trial is sponsored by Nicoletta C Machin, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04344860's enrollment target sits among peer trials
20 1956th of 2000 higher than 32 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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