Vasculitis Pregnancy Registry

NCT ID: NCT02593565

Last Updated: 2026-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

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

Online questionnaires

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Online questionnaires

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Duke University

OTHER

Sponsor Role collaborator

University of South Florida

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Megan Clowse, MD, MPH

Role: STUDY_CHAIR

Duke University

Peter A Merkel, MD, MPH

Role: STUDY_CHAIR

University of Pennsylvania

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of South Florida Data Management and Coordinating Center

Tampa, Florida, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Christine Yeung

Role: CONTACT

Carol McAlear, MA

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Cristina Burroughs

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 38825354 (View on PubMed)

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.

Reference Type RESULT
PMID: 38825350 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://vpprn.org

The Vasculitis Patient-Powered Research Network

https://www.vasculitisfoundation.org/vpreg/

Vasculitis Pregnancy Registry (VPREG) Information

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VCRC 5532

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Apremilast Pregnancy Exposure Registry
NCT02775500 ACTIVE_NOT_RECRUITING
VCRC Tissue Repository
NCT02967068 RECRUITING