An observational study in Autoimmune Diseases, Pregnancy Related and Systemic Lupus Erythematosus, sponsored by Duke University. Recruiting at 1 site in United States. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by Duke University · Observational
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.
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.
Women who have been diagnosed with an autoimmune disease or a rheumatic condition.
Exclusion Criteria:
Women with autoimmune diseases who are pregnant
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.
Time frame: up to 10 years
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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