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RecruitingNCT02593565V-PREGUpdated Jan 23, 2026

Vasculitis Pregnancy Registry

An observational study in Vasculitis, Behcet's Disease and CNS Vasculitis, sponsored by University of Pennsylvania. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-01-23.

Sponsored by University of Pennsylvania · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 50 Years
Sex
Female
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Study summary

The purpose of this study is to learn about the experience of women with vasculitis who become pregnant. In particular, the study will consist of several online surveys to assess

  1. each woman's vasculitis severity and pregnancy-related experiences, and
  2. pregnancy outcomes.
Read the detailed description

The study will consist of several on-line surveys to assess each woman's vasculitis severity, pregnancy-related experiences, and pregnancy outcomes. Participants will be asked to complete questionnaires at study entry, during the second trimester, during the third trimester, and postpartum. Investigators estimate that it will take approximately 20 minutes to complete each survey. The survey is available in Spanish, Portuguese, Italian, and Turkish.

All women enrolled in the Vasculitis Patient-Powered Research Network (VPPRN) (with specified disease, sex, and age inclusion criteria described below) will be invited via email to participate in this on-line study. The survey data will be stored by the Data Management and Coordinating Center (DMCC) at the University of South Florida. Upon conclusion of the study period, the data will be sent to the Study Chairs.

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Conditions studied

  • Vasculitis
  • Behcet's Disease
  • CNS Vasculitis
  • Cryoglobulinemic Vasculitis
  • Eosinophilic Granulomatosis With Polyangiitis (EGPA)
  • Churg-Strauss Syndrome (CSS)
  • Granulomatosis With Polyangiitis (GPA)
  • Wegener's Granulomatosis
  • IgA Vasculitis
  • Henoch-Schoenlein Purpura (HSP)
  • Microscopic Polyangiitis (MPA)
  • Polyarteritis Nodosa (PAN)
  • Takayasu Arteritis (TAK)
  • Urticarial Vasculitis
  • Systemic Vasculitis
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In context

Vasculitis

170 studies on the registry are indexed under Vasculitis; 46 are open to participants now.

This study's planned enrollment of 100 is below the median of 147 across 77 observational studies indexed under Vasculitis.

Browse Vasculitis studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.

Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women with vasculitis who are currently pregnant.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Women 18 years of age or older with one of the following diseases may take part in the study:

    • Behçet's disease;
    • Central nervous system (CNS) vasculitis;
    • Cryoglobulinemic vasculitis (Cryoglobulinemia);
    • Eosinophilic granulomatosis with polyangiitis (also called Churg-Strauss Syndrome);
    • Giant Cell (Temporal) Arteritis (GCA);
    • Granulomatosis with polyangiitis (also called Wegener's);
    • IgA vasculitis (Henoch-Schoenlein purpura);
    • Microscopic polyangiitis (MPA);
    • Polyarteritis nodosa (PAN);
    • Takayasu's arteritis (TAK);
    • Urticarial vasculitis;
    • Other/Suspected Diagnosis.
  2. Women must be pregnant (self-report) at the time of enrollment into the registry.

Exclusion criteria

Exclusion Criteria:

  1. Non-English speaking, with the exception of people who speak Spanish, Portuguese, Italian, or Turkish.
  2. Unable to provide consent.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes

Groups and cohorts

  • Intervention

    Woman, 18 years of age or older, currently pregnant, and have a diagnosis of vasculitis.

    Other: Online questionnaires

Interventions

  • OtherOnline questionnaires

    Women will be asked to complete questionnaires during their pregnancy and a postpartum questionnaire.

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What researchers measure

Primary outcomes

  1. Unique pregnancy characteristics among women with vasculitis.

    To understand pregnancy characteristics and outcomes among women with vasculitis using patient-reported questionnaires in each trimester.

    Time frame: Four years

07

Study locations

1 of 1 sites recruiting
  • University of South Florida Data Management and Coordinating Center
    Tampa, Florida 33612, United States
    Recruiting
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References and documents

Publications

  • Sims CA, Eudy AM, Larson K, Yeung C, Tam H, Kullman J, Borchin RL, Burroughs C, Merkel PA, Clowse MEB; VPREG Collaborative Group. Reproductive Outcomes for Women With Vasculitis. J Rheumatol. 2024 Oct 1;51(10):1003-1008. doi: 10.3899/jrheum.2023-1246. PubMed 38825354 ↗
  • Sims CA, Perry B, Yeung C, Tam H, Kullman J, Borchin RL, Burroughs C, Merkel PA, Clowse MEB. Exploring Reproductive Experiences With Women Enrolled in the International Vasculitis Pregnancy Registry. J Rheumatol. 2024 Oct 1;51(10):997-1002. doi: 10.3899/jrheum.2023-1055. PubMed 38825350 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02593565
Responsible party
Sponsor
First posted
Nov 2, 2015
Start date
Nov 2015
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jan 23, 2026

Study contacts

Carol McAlear, MA
Contact
cmcalear@upenn.edu
Megan Clowse, MD, MPH
study chair · Duke University
Peter A Merkel, MD, MPH
study chair · University of Pennsylvania

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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