Maternal Autoimmune Disease Research Alliance (MADRA) Registry

Study Overview
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Brief Summary
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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.

Detailed Description
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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 medications, laboratory testing, or procedures outside of the standard of care. Management of the rheumatologic disease will be directed based on patient needs by the local rheumatologist and obstetrician. Enrollment in the registry will not dictate specific therapy. The Registry will include data from each office visit during pregnancy and up to 12 months after delivery. The registry will be ongoing, with periodic analysis of clinical data samples as specific studies are approved. Enrollment in the registry does not significantly increase risks for a patient.

Official Title
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Maternal Autoimmune Disease Research Alliance (MADRA) Registry

Conditions
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Autoimmune Diseases, Pregnancy Related, Systemic Lupus Erythematosus, Cutaneous Lupus, Rheumatoid Arthritis, Sjogren's Syndrome, Scleroderma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: Unable to speak English Unable to provide informed consent Unable to travel to Duke University for follow-up visits
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Maternal Autoimmune Disease ReseArch (MADRA) Registry<br>Women with autoimmune diseases who are pregnant | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors associated with poor pregnancy outcomes as measured by the MADRA-DAP questionnaire. | The investigators will ask the participants questions from the MADRA-DAP questionnaire to determine poor pregnancy outcomes. | up to 10 years |