Status:
RECRUITING
Maternal Autoimmune Disease Research Alliance (MADRA) Registry
Lead Sponsor:
Duke University
Conditions:
Autoimmune Diseases
Pregnancy Related
Eligibility:
FEMALE
Brief 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...
Detailed Description
At each site, the patients will be under the care of the participating rheumatologist and their local obstetrician during the pregnancy. This is a natural-history study and will not include medication...
Eligibility Criteria
Inclusion
- 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
- Unable to speak English
- Unable to provide informed consent
- Unable to travel to Duke University for follow-up visits
Key Trial Info
Start Date :
January 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT03276923
Start Date
January 1 2018
End Date
January 1 2027
Last Update
January 8 2026
Active Locations (1)
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1
Duke University
Durham, North Carolina, United States, 27705