Trial Outcomes & Findings for Prevent Postpartum Hemorrhage in Women With Von Willebrand Disease: The VWD-WOMAN Trial (NCT NCT04344860)

NCT ID: NCT04344860

Last Updated: 2025-10-31

Results Overview

Blood loss at delivery by standard QBL measured for 6 hours postpartum by the labor and delivery nursing staff.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

20 participants

Primary outcome timeframe

6hrs

Results posted on

2025-10-31

Participant Flow

Participants were screened and enrolled during routine clinic visits at the Hemophilia Center of Western Pennsylvania, with delivery planned at UPMC Magee-Womens Hospital in Pittsburgh, Pennsylvania. The study was approved by the University of Pittsburgh Biomedical Institutional Review Board April 28, 2021, and between June 4, 2021 and May 17, 2024, 20 patients were enrolled.

Participant milestones

Participant milestones
Measure	rVWF plus TA Subjects randomized to this arm will receive recombinant von Willebrand factor 80 IU/kg IV within 5-10 minutes of delivery (or epidural anesthesia) plus Tranexamic Acid 1 gm IV within 3 hours of delivery; and recombinant Von Willebrand factor 80 IU/kg on day 1 and day 2 postpartum.	rVWF alone Subjects randomized to this arm will receive recombinant von Willebrand factor 80 IU/kg IV within 5-10 minutes of delivery (or epidural anesthesia); and recombinant Von Willebrand factor 80 IU/kg on day 1 and day 2 postpartum.
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prevent Postpartum Hemorrhage in Women With Von Willebrand Disease: The VWD-WOMAN Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	rVWF plus TA n=10 Participants Subjects randomized to this arm will receive recombinant von Willebrand factor 80 IU/kg IV within 5-10 minutes of delivery (or epidural anesthesia) plus Tranexamic Acid 1 gm IV within 3 hours of delivery; and recombinant Von Willebrand factor 80 IU/kg on day 1 and day 2 postpartum.	rVWF alone n=10 Participants Subjects randomized to this arm will receive recombinant von Willebrand factor 80 IU/kg IV within 5-10 minutes of delivery (or epidural anesthesia); and recombinant Von Willebrand factor 80 IU/kg on day 1 and day 2 postpartum.	Total n=20 Participants Total of all reporting groups
Age, Continuous	29.1 years STANDARD_DEVIATION 5.2 • n=5 Participants	28.8 years STANDARD_DEVIATION 5.3 • n=7 Participants	29.0 years STANDARD_DEVIATION 5.3 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ferritin	18 ng/mL STANDARD_DEVIATION 11.1 • n=5 Participants	13.5 ng/mL STANDARD_DEVIATION 6.5 • n=7 Participants	15.8 ng/mL STANDARD_DEVIATION 9.1 • n=5 Participants
Third Trimester Hemoglobin	12.1 dL STANDARD_DEVIATION 0.9 • n=5 Participants	11.8 dL STANDARD_DEVIATION 1.0 • n=7 Participants	11.9 dL STANDARD_DEVIATION 0.9 • n=5 Participants
VWF:Ag 3rd trimester	1.9 IU/mL STANDARD_DEVIATION 1.1 • n=5 Participants	1.4 IU/mL STANDARD_DEVIATION 1.1 • n=7 Participants	1.7 IU/mL STANDARD_DEVIATION 1.1 • n=5 Participants
Number of participant with type 1 von Willebrand disease	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6hrs

Blood loss at delivery by standard QBL measured for 6 hours postpartum by the labor and delivery nursing staff.

Outcome measures

Outcome measures
Measure	rVWF plus TA n=10 Participants Subjects randomized to this arm will receive recombinant von Willebrand factor 80 IU/kg IV within 5-10 minutes of delivery (or epidural anesthesia) plus Tranexamic Acid 1 gm IV within 3 hours of delivery; and recombinant Von Willebrand factor 80 IU/kg on day 1 and day 2 postpartum.	rVWF alone n=10 Participants Subjects randomized to this arm will receive recombinant von Willebrand factor 80 IU/kg IV within 5-10 minutes of delivery (or epidural anesthesia); and recombinant Von Willebrand factor 80 IU/kg on day 1 and day 2 postpartum.
Volume of Quantitative Blood Loss at Delivery	727.0 mL Standard Deviation 802.5	539.7 mL Standard Deviation 355.08

SECONDARY outcome

Timeframe: 21 days

Population: One subject in the rVWF+ TA arm did not complete a PBAC diary and was excluded from this exploratory analysis.

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.

Outcome measures

Outcome measures
Measure	rVWF plus TA n=9 Participants Subjects randomized to this arm will receive recombinant von Willebrand factor 80 IU/kg IV within 5-10 minutes of delivery (or epidural anesthesia) plus Tranexamic Acid 1 gm IV within 3 hours of delivery; and recombinant Von Willebrand factor 80 IU/kg on day 1 and day 2 postpartum.	rVWF alone n=10 Participants Subjects randomized to this arm will receive recombinant von Willebrand factor 80 IU/kg IV within 5-10 minutes of delivery (or epidural anesthesia); and recombinant Von Willebrand factor 80 IU/kg on day 1 and day 2 postpartum.
Blood Loss Postpartum by Pictorial Bleeding Assessment Chart (PBAC)	467.1 Scores on a scale Standard Deviation 442.0	344.8 Scores on a scale Standard Deviation 315.5

SECONDARY outcome

Timeframe: 21 days

Population: All subjects were included in this analysis.

Number of transfused blood products determined by electronic medical record review and patient diary.

Outcome measures

Outcome measures
Measure	rVWF plus TA n=10 Participants Subjects randomized to this arm will receive recombinant von Willebrand factor 80 IU/kg IV within 5-10 minutes of delivery (or epidural anesthesia) plus Tranexamic Acid 1 gm IV within 3 hours of delivery; and recombinant Von Willebrand factor 80 IU/kg on day 1 and day 2 postpartum.	rVWF alone n=10 Participants Subjects randomized to this arm will receive recombinant von Willebrand factor 80 IU/kg IV within 5-10 minutes of delivery (or epidural anesthesia); and recombinant Von Willebrand factor 80 IU/kg on day 1 and day 2 postpartum.
Number of Blood Products Used	0 Number of transfused blood products	0 Number of transfused blood products

SECONDARY outcome

Timeframe: 21 days

Population: 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.

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.

Outcome measures

Outcome measures
Measure	rVWF plus TA n=10 Participants Subjects randomized to this arm will receive recombinant von Willebrand factor 80 IU/kg IV within 5-10 minutes of delivery (or epidural anesthesia) plus Tranexamic Acid 1 gm IV within 3 hours of delivery; and recombinant Von Willebrand factor 80 IU/kg on day 1 and day 2 postpartum.	rVWF alone n=10 Participants Subjects randomized to this arm will receive recombinant von Willebrand factor 80 IU/kg IV within 5-10 minutes of delivery (or epidural anesthesia); and recombinant Von Willebrand factor 80 IU/kg on day 1 and day 2 postpartum.
Concentration of Von Willebrand Factor Third trimester VWF:Ag	1.89 IU/mL Standard Deviation 1.1	1.41 IU/mL Standard Deviation 0.6
Concentration of Von Willebrand Factor Admission VWF:Ag	2.20 IU/mL Standard Deviation 1.1	2.00 IU/mL Standard Deviation 1.0
Concentration of Von Willebrand Factor 24h postpartum VWF:Ag	3.3 IU/mL Standard Deviation 0.9	3.4 IU/mL Standard Deviation 1.3
Concentration of Von Willebrand Factor 48h postpartum VWF:Ag	4.0 IU/mL Standard Deviation 1.2	3.5 IU/mL Standard Deviation 0.9
Concentration of Von Willebrand Factor 21 days postpartum VWF:Ag	0.9 IU/mL Standard Deviation 0.7	0.9 IU/mL Standard Deviation 0.3
Concentration of Von Willebrand Factor Third trimester VWF:RCo	1.00 IU/mL Standard Deviation 0.5	1.08 IU/mL Standard Deviation 0.7
Concentration of Von Willebrand Factor Admission VWF:RCo	0.97 IU/mL Standard Deviation 0.5	1.1 IU/mL Standard Deviation 0.6
Concentration of Von Willebrand Factor 24h postpartum VWF:RCo	1.9 IU/mL Standard Deviation 0.9	2.2 IU/mL Standard Deviation 0.9
Concentration of Von Willebrand Factor 48h postpartum VWF:Rco	2.3 IU/mL Standard Deviation 0.6	2.1 IU/mL Standard Deviation 0.8
Concentration of Von Willebrand Factor 21 days postpartum VWF:RCo	0.5 IU/mL Standard Deviation 0.2	0.5 IU/mL Standard Deviation 0.2

Adverse Events

rVWF plus TA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

rVWF alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nicoletta Machin

University Of Pittsburgh

Phone: (412) 209-7280

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place