Trial · NCT04344860
Prevent Postpartum Hemorrhage in Women With Von Willebrand Disease: The VWD-WOMAN Trial
NCT04344860, Phase 3, Completed, Nicoletta C Machin; results first posted 2025-10-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Prevent Postpartum Hemorrhage in Women With Von Willebrand Disease: The VWD-WOMAN Trial. Trials, record NCT04344860. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04344860
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prevent Postpartum Hemorrhage in Women With Von Willebrand Disease: The VWD-WOMAN Trial
- NCT number
- NCT04344860
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 20 participants, actual
- Lead sponsor
- Nicoletta C Machin
- Conditions
- Von Willebrand Diseases, Postpartum Hemorrhage
- Interventions
- Recombinant Von Willebrand factor, Tranexamic Acid Injection [Cyklokapron]
- First posted
- 2020-04-14
- Last updated
- 2025-10-31
- Results first posted
- 2025-10-31
- Limitations and caveats
There are several limitations of this study. First, the small sample size and pilot nature of this study restrict the generalizability of the findings. Further, as findings in type 1 VWD may not predict those with more severe disease, future studies should include pregnant females with type 2 and 3 VWD.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Volume of Quantitative Blood Loss at Delivery | 6hrs | Blood loss at delivery by standard QBL measured for 6 hours postpartum by the labor and delivery nursing staff. |
| Secondary | Blood Loss Postpartum by Pictorial Bleeding Assessment Chart (PBAC) | 21 days | Blood loss postpartum by pictorial bleeding assessment chart (PBAC). Participants record the degree of saturation of sanitary products and the presence of clots. Total PBAC scores range from 0 to \>500, with higher scores indicating heavier menstrual bleeding. A score ≥100 is conventionally consistent with heavy bleeding. Each sanitary product is assigned a score reflecting the amount of blood loss: Pads: 1 (point) for lightly stained, 5 for moderately soiled, 20 for fully soaked Tampons: 1 for lightly stained, 5 for moderately soiled, 10 for fully soaked Clots: 1 point for small (\<1 cm), 5 for large (\>1 cm) Daily scores are summed to produce a total cycle PBAC score. Subscale items (pads and clots) were summed to obtain a total PBAC score. |
| Secondary | Number of Blood Products Used | 21 days | Number of transfused blood products determined by electronic medical record review and patient diary. |
| Secondary | Concentration of Von Willebrand Factor | 21 days | Plasma levels of von Willebrand Factor antigen (VWF:Ag) and activity (VWF:RCo) measured during the peripartum period. Higher concentrations indicate greater clotting factor activity. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Volume of Quantitative Blood Loss at Delivery | 6hrs | mL | MEAN | |
| SECONDARY | Blood Loss Postpartum by Pictorial Bleeding Assessment Chart (PBAC) | 21 days | One subject in the rVWF+ TA arm did not complete a PBAC diary and was excluded from this exploratory analysis. | Scores on a scale | MEAN |
| SECONDARY | Number of Blood Products Used | 21 days | All subjects were included in this analysis. | Number of transfused blood products | NUMBER |
| SECONDARY | Concentration of Von Willebrand Factor | 21 days | All randomized participants (N=20; 10 per arm) were included in the analysis. For von Willebrand factor laboratory outcomes (VWF:Ag, VWF:RCo), not all participants contributed data at every time point due to missed blood draws. Specifically, one participant in the rVWF+TXA arm had missing values at 48 hours postpartum and at 21 days postpartum. Therefore, the analysis population for those time points is n=9 in the rVWF+TXA arm and n=10 in the rVWF-alone arm. | IU/mL | MEAN |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Volume of Quantitative Blood Loss at Delivery | rVWF plus TA | 727.0 | Standard Deviation 802.5 | mL | |
| Volume of Quantitative Blood Loss at Delivery | rVWF alone | 539.7 | Standard Deviation 355.08 | mL | |
| Blood Loss Postpartum by Pictorial Bleeding Assessment Chart (PBAC) | rVWF plus TA | 467.1 | Standard Deviation 442.0 | Scores on a scale | |
| Blood Loss Postpartum by Pictorial Bleeding Assessment Chart (PBAC) | rVWF alone | 344.8 | Standard Deviation 315.5 | Scores on a scale | |
| Number of Blood Products Used | rVWF plus TA | 0 | Number of transfused blood products | ||
| Number of Blood Products Used | rVWF alone | 0 | Number of transfused blood products | ||
| Concentration of Von Willebrand Factor | rVWF plus TA | Third trimester VWF:Ag | 1.89 | Standard Deviation 1.1 | IU/mL |
| Concentration of Von Willebrand Factor | rVWF alone | Third trimester VWF:Ag | 1.41 | Standard Deviation 0.6 | IU/mL |
| Concentration of Von Willebrand Factor | rVWF plus TA | Admission VWF:Ag | 2.20 | Standard Deviation 1.1 | IU/mL |
| Concentration of Von Willebrand Factor | rVWF alone | Admission VWF:Ag | 2.00 | Standard Deviation 1.0 | IU/mL |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | rVWF plus TA | 10 | |
| Overall Study | STARTED | rVWF alone | 10 | |
| Overall Study | COMPLETED | rVWF plus TA | 10 | |
| Overall Study | COMPLETED | rVWF alone | 10 | |
| Overall Study | NOT COMPLETED | rVWF plus TA | 0 | |
| Overall Study | NOT COMPLETED | rVWF alone | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | rVWF plus TA | 0 | 10 |
| Total, all-cause mortality | rVWF alone | 0 | 10 |
| Total, other adverse events | rVWF plus TA | 0 | 10 |
| Total, other adverse events | rVWF alone | 0 | 10 |
| Total, serious adverse events | rVWF plus TA | 0 | 10 |
| Total, serious adverse events | rVWF alone | 0 | 10 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| rVWF plus TA vs rVWF alone: deaths from any cause | Trial comparisons |
| rVWF plus TA vs rVWF alone: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04344860
GET https://conductscience.org/api/trials/v1/NCT04344860/results?page=2