Actively Recruiting
Maternal Autoimmune Disease Research Alliance (MADRA) Registry Observational Study of Pregnant Women with Autoimmune Diseases
Led by Duke University · Updated on 2026-01-08
1000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are enrolling pregnant women or those planning pregnancy within 6 months who have autoimmune and rheumatologic diseases. The study aims to better understand risk factors related to increased inflammation before and during pregnancy that may affect the health of both mothers and their babies. This registry study collects data over several years to help improve outcomes for women with rheumatic diseases. Participants will remain under the care of their own rheumatologist and obstetrician throughout pregnancy. This observational study does not involve extra treatments, medications, lab tests, or procedures outside standard care. Data from routine office visits during pregnancy and for up to 12 months after delivery will be collected and analyzed periodically. Women enrolled will provide health information through their regular medical visits without added risks. Researchers will track outcomes related to pregnancy risks using tools like the MADRA-DAP questionnaire over up to 10 years. The study is ongoing with periodic reviews to better define factors influencing pregnancy health in women with autoimmune diseases.
CONDITIONS
Brief Title
Maternal Autoimmune Disease Research Alliance (MADRA) Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Desire for pregnancy within 6 months or currently pregnant
- Women with systemic autoimmune diseases including lupus (systemic or cutaneous), antiphospholipid syndrome or positive antiphospholipid antibodies, rheumatoid arthritis, scleroderma, Sjogren's syndrome, inflammatory arthritis (including psoriatic arthritis and ankylosing spondylitis), undifferentiated connective tissue disease, vasculitis, myositis (polymyositis or dermatomyositis), or positive Ro/SSA or La/SSB antibodies
You will not qualify if you...
- Unable to speak English
- Unable to provide informed consent
- Unable to travel to Duke University for follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of pregnancy
Participants who undergo routine care are observed during pregnancy with data collected from each office visit.
Multiple office visits during pregnancy
Duration - Up to 12 months after delivery
Participants are monitored for up to 12 months after delivery with data collected from each office visit.
Multiple office visits up to 12 months post-delivery
Trial Site Locations
Total: 1 location
1
Duke University
Durham, North Carolina, United States, 27705
Actively Recruiting
Research Team
L
Laura Neil
E
Edna Scarlett
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here