What this study is
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.
Study details
- Sponsor
- Duke University
- Conditions
- Autoimmune Diseases · Pregnancy Related · Systemic Lupus Erythematosus · Cutaneous Lupus · Rheumatoid Arthritis · Sjogren's Syndrome · Scleroderma
- Enrolling
- 1,000 people
- Starts
- 2018-01-01
- Est. completion
- 2027-01-01
- Record
- View on ClinicalTrials.gov ↗
Who can join
Sex FEMALEHealthy volunteers AcceptedYou may qualify if
- 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
You can't join if
- Unable to speak English
- Unable to provide informed consent
- Unable to travel to Duke University for follow-up visits
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openDuke University
Durham, North Carolina, United States
- Megan Clowse, MD · Contact919 681 2045megan.clowse@duke.edu
- Laura Neil · Contact919 684 8936laura.k.neil@duke.edu
Recruiting
Study team
Sponsor
Duke University
Study ID Pro00084014
Principal investigator
Megan EB Clowse, MD, MPH
Duke Health
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.