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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 is a Phase 3 study that has completed, run by Nicoletta C Machin. The registered enrollment target is 20 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04344860
The ClinicalTrials.gov registry entry for NCT04344860 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nicoletta C Machin, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Recombinant Von Willebrand factor is the first listed.
NCT04344860 reports 0 study locations.
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.
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