NCT03276923 Maternal Autoimmune Disease Research Alliance (MADRA) Registry
| NCT ID | NCT03276923 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Autoimmune Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2018-01-01 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2018-01-01 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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
Contact & Investigator
Megan EB Clowse, MD, MPH
PRINCIPAL INVESTIGATOR
Duke Health
Frequently Asked Questions
Who can join the NCT03276923 clinical trial?
This trial is open to female participants only, studying Autoimmune Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03276923 currently recruiting?
Yes, NCT03276923 is actively recruiting participants. Contact the research team at laura.k.neil@duke.edu for enrollment information.
Where is the NCT03276923 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT03276923 clinical trial?
NCT03276923 is sponsored by Duke University. The principal investigator is Megan EB Clowse, MD, MPH at Duke Health. The trial plans to enroll 1,000 participants.