Trials / Recruiting
RecruitingNCT03276923
Maternal Autoimmune Disease Research Alliance (MADRA) Registry
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,000 (estimated)
- Sponsor
- Duke University · Academic / Other
- Sex
- Female
- Age
- —
- Healthy volunteers
- Accepted
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.
Detailed description
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.
Conditions
- Autoimmune Diseases
- Pregnancy Related
- Systemic Lupus Erythematosus
- Cutaneous Lupus
- Rheumatoid Arthritis
- Sjogren's Syndrome
- Scleroderma
Timeline
- Start date
- 2018-01-01
- Primary completion
- 2027-01-01
- Completion
- 2027-01-01
- First posted
- 2017-09-08
- Last updated
- 2026-01-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03276923. Inclusion in this directory is not an endorsement.