Duke University
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.
Autoimmune Diseases
Pregnancy Related
Systemic Lupus Erythematosus
Cutaneous Lupus
Rheumatoid Arthritis
Sjogren's Syndrome
Scleroderma
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.
| Study Type : | OBSERVATIONAL |
| Estimated Enrollment : | 1000 participants |
| Official Title : | Maternal Autoimmune Disease Research Alliance (MADRA) Registry |
| Actual Study Start Date : | 2018-01-01 |
| Estimated Primary Completion Date : | 2027-01-01 |
| Estimated Study Completion Date : | 2027-01-01 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | |
| Sexes Eligible for Study: | FEMALE |
| Accepts Healthy Volunteers: | 1 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Duke University
Durham, North Carolina, United States, 27705