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Reproductive Health in Men and Women With Vasculitis

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ClinicalTrials.gov Identifier: NCT02176070
Recruitment Status : Completed
First Posted : June 26, 2014
Last Update Posted : June 26, 2014
Sponsor:
Collaborators:
Duke University
Boston University
Data Management and Coordinating Center (DMCC)
Information provided by (Responsible Party):
University of South Florida

Brief Summary:
The purpose of this study is to learn about reproductive health, including fertility and pregnancies, in people with vasculitis.

Condition or disease
Giant Cell Arteritis Takayasu's Arteritis Polyarteritis Nodosa Wegener's Granulomatosis Microscopic Polyangiitis Churg-Strauss Syndrome Behcet's Disease Kawasaki Disease Henoch-schoenlein Purpura Vasculitis, Central Nervous System Drug-induced Necrotizing Vasculitis

Detailed Description:
All patients enrolled in the Vasculitis Clinical Research Consortium's Contact Registry were invited via email to participate in this study. The Contract Registry includes people who self-identify as having one of 6 vasculitities: Wegener's Granulomatosis, Microscopic Polyangiitis, Churg-Strauss Syndrome, Polyarteritis Nodosum, Takayasu's Arteritis, and Giant Cell Arteritis. People voluntarily enroll in this Registry with the understanding that they will receive information about clinical studies for which they might be eligible. The introductory email included basic information about the study and all of the required elements for informed consent in a brief format. By clicking the link to the reproductive health questionnaire, participants gave their consent to be included in the study.

Study Type : Observational [Patient Registry]
Actual Enrollment : 467 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Year
Official Title: Reproductive Health in Men and Women With Vasculitis
Study Start Date : February 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012





Primary Outcome Measures :
  1. The rate of infertility with and without prior cyc. [ Time Frame: 1 year after the study is closed to enrollment ]

Secondary Outcome Measures :
  1. The rate of pregnancy complications in pregnancies delivered before and after vasculitis diagnosis. [ Time Frame: 1 year after the study is closed to enrollment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with vasculitis included in the VCRC Contact Registry were invited to participate. Data was included for all patients who provided a vasculitis diagnosis, estimated date of diagnosis, confirmed that the diagnosis was made by a rheumatologist, and reported having taken at least one appropriate anti-rheumatic medication. Other participants were excluded as the likelihood that they have a true vasculitis condition is low.
Criteria

Inclusion Criteria:

  • Enrolled in VCRC Contact Registry
  • Patient reported diagnosis of Wegener's Granulomatosis, Microscopic Polyangiitis, Churg-Strauss Syndrome, Polyarteritis Nodosa, Takayasu's Arteritis, Giant Cell Arteritis, Behcet's Disease, Kawasaki Disease, Henoch-Schoenlein Purpura, CNS or Drug-induced Vasculitis
  • 18 years of age or older
  • English speaking

Exclusion Criteria:

  • Inability to provide informed consent and complete survey

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02176070


Locations
United States, Florida
University of South Florida Data Management Coordinating Center
Tampa, Florida, United States, 33612
Sponsors and Collaborators
University of South Florida
Duke University
Boston University
Data Management and Coordinating Center (DMCC)
Investigators
Study Chair: Megan Clowse, MD, MPH Duke University
Study Chair: Amanda M. Terry, MA USF College of Medicine

Additional Information:
Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT02176070     History of Changes
Other Study ID Numbers: 5531
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: June 26, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Behcet Syndrome
Purpura
Vasculitis
Arteritis
Systemic Vasculitis
Granulomatosis with Polyangiitis
Giant Cell Arteritis
Polymyalgia Rheumatica
Mucocutaneous Lymph Node Syndrome
Takayasu Arteritis
Aortic Arch Syndromes
Microscopic Polyangiitis
Churg-Strauss Syndrome
Purpura, Schoenlein-Henoch
Polyarteritis Nodosa
Vasculitis, Central Nervous System
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Panuveitis
Uveitis
Uveal Diseases