RecruitingNCT03276923

Maternal Autoimmune Disease Research Alliance (MADRA) Registry


Sponsor

Duke University

Enrollment

1,000 participants

Start Date

Jan 1, 2018

Study Type

OBSERVATIONAL

Conditions

Summary

This multi-site registry, centered at Duke University, will enroll pregnant women with autoimmune and rheumatologic diseases. The main goal of MADRA is to identify ways to improve the health of women with rheumatic diseases and their babies during pregnancy. Prior studies demonstrate the importance of increase inflammation prior to and during pregnancy on these outcomes. The future research will seek to better define these risk factors and to identify ways to may improve them.


Eligibility

Sex: FEMALE

Inclusion Criteria12

  • Desire for pregnancy within 6 months or currently pregnant
  • Women with systemic autoimmune disease, including:
  • Lupus (systemic lupus erythematosus or cutaneous lupus)
  • Antiphospholipid Syndrome or positive antiphospholipid antibodies
  • Rheumatoid Arthritis
  • Scleroderma (systemic sclerosis)
  • Sjogren's Syndrome
  • Inflammatory Arthritis (including Psoriatic Arthritis and Ankylosing Spondylitis)
  • Undifferentiated Connective Tissue Disease (UCTD)
  • Vasculitis
  • Myositis (Polymyositis or Dermatomyositis)
  • Positive Ro/SSA or La/SSB antibodies

Exclusion Criteria3

  • Unable to speak English
  • Unable to provide informed consent
  • Unable to travel to Duke University for follow-up visits

Locations(1)

Duke University

Durham, North Carolina, United States

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NCT03276923


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