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Von Willebrand DiseasesVIPNCT04146376

Von Willebrand Factor in Pregnancy (VIP) Study

An observational study of Von Willebrand Diseases, run by University of Washington at 11 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

In pregnant women with von Willebrand disease (VWD) who by the third trimester do not have von Willebrand factor (VWF) or factor VIII (FVIII) levels greater than 50-100%, specific guidance is lacking for delivery planning in terms of how high of a VWF level should be achieved to reduce bleeding. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Von Willebrand Diseases
What is being tested?
Use of a postpartum diary and additional blood draws, VWF replacement therapy with Wilate and Tranexamic acid
How many people
110 participants
Where
11 sitesUnited States
Study dates
12 Oct 2019to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: The investigators or qualified research personnel will approach all consecutive pregnant VWD patients. Patients who meet all of the inclusion criteria and none of the exclusion criteria are eligible for this study.

Who may be able to join

  • von Willebrand Disease (VWD) patients defined prepartum as Type 1 per National Heart, Lung, and Blood Institute (NHLBI) criterion of von Willebrand Factor (VWF) level less than 30 percent, or Type 2, or Type 3 VWD
  • or
  • A diagnosis of VWD and VWF and Factor VIII (FVIII) levels obtained in gestational weeks 34-38 that determine enrollment in the non-corrector group:
  • Patients with gestational week 34-38 VWF:Ag, VWF:Act (or VWF:RCo), or FVIII:C less than 100 percent will be enrolled in the non-corrector group. In patients with an isolated VWF:CB type 2 defect, VWF:CB less than 100 percent can also be determined as a non-corrector
  • Patients with all VWF parameter levels greater than or equal to 100 percent self-corrected at gestational weeks 34-38 will be enrolled in the corrector group
  • Written informed consent from the patient prepartum, before gestational week 39

Who cannot join

  • Presence of a clinical contraindication to receive wilate or tranexamic acid, as determined by the health care provider, such as a prior drug reaction
  • Presence of other concurrent disorder of hemostasis, platelet dysfunction, or collagen disorders
  • Presence of liver disease or renal disease, clinical suspicion or diagnosis of preeclampsia or eclampsia, HELLP syndrome, TTP, DIC, or other acquired vasculopathy or coagulopathy
  • Age less than 18 years
  • Inability of the local laboratory to monitor the VWF laboratory tests needed during the course of treatment to determine Wilate dosing adjustments

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Central Study Contact contact

919-792-3740

VIP.Study@ergomedgroup.com

11 sites in 1 country

United States11 sites, 10 recruiting

  • Emory University

    Atlanta, Georgia, 30308

    Lucy Sanchez, 407-879-4446, lucy.sanchez@emory.edu

    Christine Kempton, MD, MSc

    Recruiting

  • University of Colorado

    Aurora, Colorado, 80045

    Julie Smith, 303-724-6187, julie.smith@cuanschutz.edu

    Genevieve Moyer, MD

    Recruiting

  • The Pennsylvania State University

    Hershey, Pennsylvania, 17033

    Cynthia Campbell-Baird, cbaird@pennstatehealth.psu.edu

    Peter Cygan, MD

    Recruiting

  • University of Miami

    Miami, Florida, 33136

    Jemima Duroseau, BSN, RN, MPH, 305-243-0796, jxp431@med.miami.edu

    Michael Paidas, MD

    Recruiting

  • Vanderbilt University

    Nashville, Tennessee, 27232

    Jadeah Jackson, 615-327-7184, jadeah.b.jackson@vumc.org

    Shannon Walker, MD

    Recruiting

  • Yale University

    New Haven, Connecticut, 06510

    Evangelia Louizos, 203-843-6358, e.louizos@yale.edu

    Robert Bona, MD

    Recruiting

  • Tulane University School of Medicine, Louisiana Center for Bleeding and Clotting Disorders

    New Orleans, Louisiana, 70112

    Melody Benton, MPH,MAS,CCRP, 504-988-3596, mbenton@tulane.edu

    Maissaa Janbain, MD

    Recruiting

  • Bleeding & Clotting Disorders Institute

    Peoria, Illinois, 61615

    Jonathan Roberts, MD, 309-692-5337, jroberts@ilbcdi.org

    Jonathan Roberts, MD

    Recruiting

  • Oregon Health & Science University

    Portland, Oregon, 97239

    Withdrawn

  • University of Utah

    Salt Lake City, Utah, 84108

    Emily Powers, 801-587-0640, emily.powers@hsc.utah.edu

    Ming Lim, MBBCh, MS

    Recruiting

  • Washington Center for Bleeding Disorders

    Seattle, Washington, 98104

    Sarah Ruuska, MPH, 206-689-6193, sarah.ruuska@WACBD.org

    Allison Wheeler, MD

    Recruiting

Other trials in United States

About this study

Official title: Von Willebrand Factor in Pregnancy (VIP) Study: A Multicenter Study of Wilate Use in Von Willebrand Disease for Childbirth

In pregnant women with von Willebrand disease (VWD) who by the third trimester do not have von Willebrand factor (VWF) or factor VIII (FVIII) levels greater than 50-100%, specific guidance is lacking for delivery planning in terms of how high of a VWF level should be achieved to reduce bleeding.

This is a prospective, open-label, cohort study in women with VWD using Wilate VWF replacement therapy to maintain trough or minimum VWF levels of 100-150% for delivery and the immediate postpartum period, followed by levels of 50-100% for 5-10 days after delivery, depending upon the route of delivery. The primary objective is to document the rate of primary postpartum hemorrhage (PPH). The secondary objective is to document further effectiveness outcomes and safety.

Read the detailed description

For pregnant women with von Willebrand disease (VWD) who by the third trimester do not have von Willebrand factor (VWF) or factor VIII (FVIII) levels > 50-100%, specific guidance is lacking for delivery planning for how high a VWF level should be achieved. Specifically, guidance is lacking on whether VWF replacement therapy should target a VWF minimum level in the 100-150% range, i.e., a range closer to the 200-250% levels observed in normal pregnancy.

This is a prospective, open-label, cohort study using Wilate VWF replacement therapy, trough or minimum VWF levels of 100-150% will be maintained for delivery in women with VWD whose third trimester VWF levels are <100%. This group is termed "non-correctors". Women with VWD whose third trimester VWF levels spontaneously rise to >100% will be assigned to the "corrector" group, and these women will not receive VWF replacement therapy. All patients will receive tranexamic acid for 14 days postpartum. Outcome parameters will be assessed for all patients.

The investigators or qualified research personnel will approach all consecutive pregnant VWD patients until 65 non-corrector patients have completed the study protocol, and up to 30 corrector patients have completed the study protocol. Patients with gestational week 34-38 von Willebrand factor activity (VWF:Act) or von Willebrand factor ristocetin cofactor (VWF:RCo), and/or Factor VIII procoagulant activity (FVIII:C) less than 100 percent will be used to assign patients to the non-corrector group. When VWF collagen binding (VWF:CB) laboratory monitoring can be performed, patients with an isolated VWF:CB type 2 defect can also be enrolled.

Rate of primary postpartum hemorrhage, severe postpartum hemorrhage, secondary postpartum hemorrhage will be measured. Safety and secondary laboratory measures will be assessed.

Being tested
Use of a postpartum diary and additional blood draws, VWF replacement therapy with Wilate, Tranexamic acid, Use of a postpartum diary and additional blood draws.
Keywords
von Willebrand Disease, von Willebrand Factor, postpartum hemorrhage
Medical subject headings
von Willebrand Diseases, Postpartum Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Use of a postpartum diary and additional blood drawsOther

    A diary will be used to capture postpartum hemorrhage (PPH), Wilate and tranexamic acid use, other drug use, bleeding episodes, and treatment schedules.

    Several blood draws additional to what is expected for routine clinical care will also be taken.

  • VWF replacement therapy with WilateDrug

    This study design uses on-label Wilate for VWF replacement therapy for delivery and the postpartum period in VWD patients whose VWF levels are <100% in the third trimester of pregnancy

  • Tranexamic acidDrug

    This study design uses tranexamic acid for prophylaxis for postpartum hemorrhage for all women with VWD

  • Use of a postpartum diary and additional blood draws.Other

    A diary will be used to capture postpartum hemorrhage (PPH), tranexamic acid use, other drug use, bleeding episodes, and treatment schedules.

    Several blood draws additional to what is expected for routine clinical care will also be taken.

Study groups in NCT04146376
Study groupRoleWhat they receive
Non-CorrectorPatients with gestational week 34-38 von Willebrand factor activity, or von Willebrand factor ristocetin cofactor, or Factor VIII procoagulant activity less than 100 percent will be termed non-correctors. When laboratory monitoring can be performed, patients with an isolated von Willebrand factor collagen binding type 2 defect, von Willebrand factor collagen binding less than 100 percent can also be enrolled and determined as a non-corrector.
Receives: Other: Use of a postpartum diary and additional blood draws; Drug: VWF replacement therapy with Wilate; Drug: Tranexamic acid
CorrectorPatients with von Willebrand factor parameter levels greater than or equal to 100 percent self-corrected at gestational weeks 34-38 will be termed correctors.
Receives: Drug: Tranexamic acid; Other: Use of a postpartum diary and additional blood draws.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. rate of primary postpartum hemorrhage (PPH)

    defined as the estimated and/or quantified blood loss greater than or equal to 1000 mL within 24 hours postpartum; unplanned transfusion of blood products related to blood loss in the first 24 hours postpartum.

    As a subset of primary PPH, severe primary PPH is defined as the estimated and/or quantified blood loss greater than or equal to 1500 mL and/or requirement of greater than 2 units packed red blood cells within 24 hours postpartum; primary PPH greater than 1000 mL and evidence of maternal hemodynamic instability (tachycardia, hypotension) and/or end organ damage with no other etiology (oliguria, creatinine greater than 0.8, etc.)

    Measured: within 24 hours postpartum

Secondary outcomes (1)

  1. rate of secondary postpartum hemorrhage (PPH)

    excessive blood loss: any transfusions not anticipated in the antepartum birth plan and unrelated to a primary PPH, including number and type of blood component units (blood products, red blood cells, plasma, platelets, cryoprecipitate) transfused within 48 hours after diagnosis and management; any transfusions not anticipated in the antepartum birth plan and unrelated to a primary PPH, including number and type of blood component units (blood products, red blood cells, plasma, platelets, cryoprecipitate) transfused beyond 48 hours after diagnosis and management; change in antepartum hemoglobin; change in pictorial blood assessment chart (PBAC) score; number of patients needing pharmacologic or surgical interventions for bleeding (e.g., use of Bakri balloon, angiographic embolization, B-Lynch sutures, surgical arterial ligation, or hysterectomy for persistent bleeding); iron levels (serum iron, TIBC, and ferritin) 6 weeks postpartum

    Measured: 24 hours to 6 weeks postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2019
  2. Study start12 Oct 2019
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04146376
Sponsor's protocol ID
STUDY00016309
Acronym
VIP
Status last verified
Dec 2025
First submitted
29 Oct 2019
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • James AH, Konkle BA, Kouides P, Ragni MV, Thames B, Gupta S, Sood S, Fletcher SK, Philipp CS. Postpartum von Willebrand factor levels in women with and without von Willebrand disease and implications for prophylaxis. Haemophilia. 2015 Jan;21(1):81-7. doi: 10.1111/hae.12568. Epub 2014 Oct 21.

    PubMed 25333737

  • Drury-Stewart DN, Lannert KW, Chung DW, Teramura GT, Zimring JC, Konkle BA, Gammill HS, Johnsen JM. Complex changes in von Willebrand factor-associated parameters are acquired during uncomplicated pregnancy. PLoS One. 2014 Nov 19;9(11):e112935. doi: 10.1371/journal.pone.0112935. eCollection 2014.

    PubMed 25409031

  • Kouides PA. Present day management of inherited bleeding disorders in pregnancy. Expert Rev Hematol. 2016 Oct;9(10):987-95. doi: 10.1080/17474086.2016.1216312. Epub 2016 Aug 2.

    PubMed 27459638

  • Abbassi-Ghanavati M, Greer LG, Cunningham FG. Pregnancy and laboratory studies: a reference table for clinicians. Obstet Gynecol. 2009 Dec;114(6):1326-1331. doi: 10.1097/AOG.0b013e3181c2bde8.

    PubMed 19935037

  • Szecsi PB, Jorgensen M, Klajnbard A, Andersen MR, Colov NP, Stender S. Haemostatic reference intervals in pregnancy. Thromb Haemost. 2010 Apr;103(4):718-27. doi: 10.1160/TH09-10-0704. Epub 2010 Feb 19.

    PubMed 20174768

  • Huq FY, Kulkarni A, Agbim EC, Riddell A, Tuddenham E, Kadir RA. Changes in the levels of factor VIII and von Willebrand factor in the puerperium. Haemophilia. 2012 Mar;18(2):241-5. doi: 10.1111/j.1365-2516.2011.02625.x. Epub 2011 Sep 28.

    PubMed 21951573

  • Nichols WL, Hultin MB, James AH, Manco-Johnson MJ, Montgomery RR, Ortel TL, Rick ME, Sadler JE, Weinstein M, Yawn BP. von Willebrand disease (VWD): evidence-based diagnosis and management guidelines, the National Heart, Lung, and Blood Institute (NHLBI) Expert Panel report (USA). Haemophilia. 2008 Mar;14(2):171-232. doi: 10.1111/j.1365-2516.2007.01643.x.

    PubMed 18315614

  • Demers C, Derzko C, David M, Douglas J; Society of Obstetricians and Gynecologists of Canada. Gynaecological and obstetric management of women with inherited bleeding disorders. J Obstet Gynaecol Can. 2005 Jul;27(7):707-32. doi: 10.1016/s1701-2163(16)30551-5. English, French.

    PubMed 16100628

  • Mannucci PM, Franchini M, Castaman G, Federici AB; Italian Association of Hemophilia Centers. Evidence-based recommendations on the treatment of von Willebrand disease in Italy. Blood Transfus. 2009 Apr;7(2):117-26. doi: 10.2450/2008.0052-08.

    PubMed 19503633

  • Laffan MA, Lester W, O'Donnell JS, Will A, Tait RC, Goodeve A, Millar CM, Keeling DM. The diagnosis and management of von Willebrand disease: a United Kingdom Haemophilia Centre Doctors Organization guideline approved by the British Committee for Standards in Haematology. Br J Haematol. 2014 Nov;167(4):453-65. doi: 10.1111/bjh.13064. Epub 2014 Aug 12. No abstract available.

    PubMed 25113304

  • Stoof SC, van Steenbergen HW, Zwagemaker A, Sanders YV, Cannegieter SC, Duvekot JJ, Leebeek FW, Peters M, Kruip MJ, Eikenboom J. Primary postpartum haemorrhage in women with von Willebrand disease or carriership of haemophilia despite specialised care: a retrospective survey. Haemophilia. 2015 Jul;21(4):505-12. doi: 10.1111/hae.12635. Epub 2015 Feb 16.

    PubMed 25688733

  • Hawke L, Grabell J, Sim W, Thibeault L, Muir E, Hopman W, Smith G, James P. Obstetric bleeding among women with inherited bleeding disorders: a retrospective study. Haemophilia. 2016 Nov;22(6):906-911. doi: 10.1111/hae.13067. Epub 2016 Oct 5.

    PubMed 27704714

  • Janssen CA, Scholten PC, Heintz AP. A simple visual assessment technique to discriminate between menorrhagia and normal menstrual blood loss. Obstet Gynecol. 1995 Jun;85(6):977-82. doi: 10.1016/0029-7844(95)00062-V.

    PubMed 7770270

  • James AH, Jamison MG. Bleeding events and other complications during pregnancy and childbirth in women with von Willebrand disease. J Thromb Haemost. 2007 Jun;5(6):1165-9. doi: 10.1111/j.1538-7836.2007.02563.x.

    PubMed 17403089

  • Kirtava A, Drews C, Lally C, Dilley A, Evatt B. Medical, reproductive and psychosocial experiences of women diagnosed with von Willebrand's disease receiving care in haemophilia treatment centres: a case-control study. Haemophilia. 2003 May;9(3):292-7. doi: 10.1046/j.1365-2516.2003.00756.x.

    PubMed 12694520

Questions about this trial

What is this clinical trial studying?

An observational study of Von Willebrand Diseases, run by University of Washington at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Central Study Contact (919-792-3740, VIP.Study@ergomedgroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

rate of primary postpartum hemorrhage (PPH) (time frame: within 24 hours postpartum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04146376, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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