Maternal Autoimmune Disease Research Alliance (MADRA) Registry
Recruiting · NCT03276923 · Observational (researchers observe without assigning treatment) · Lead sponsor: Duke University
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
No age limits stated
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed across 1 US state.
- Duke University - Durham, North Carolina, United States