Registry for pregnant women with autoimmune diseases
Maternal Autoimmune Disease Research Alliance (MADRA) Registry
This study is trying to learn more about how autoimmune diseases affect pregnant women and their babies to help improve their health during and after pregnancy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Sex | Female |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT03276923 on ClinicalTrials.gov |
What this trial studies
The Maternal Autoimmune Disease Research Alliance (MADRA) Registry is a multi-site observational study that enrolls pregnant women diagnosed with autoimmune and rheumatologic diseases. The primary aim is to enhance the health outcomes of these women and their babies during pregnancy by identifying risk factors associated with increased inflammation. Participants will receive standard care from their local rheumatologist and obstetrician, with data collected from each office visit throughout pregnancy and up to one year postpartum. This registry will facilitate ongoing analysis of clinical data to inform future research.
Who should consider this trial
Good fit: Ideal candidates for this registry are pregnant women or those planning to become pregnant within six months who have systemic autoimmune diseases such as lupus or rheumatoid arthritis.
Not a fit: Patients who do not speak English or are unable to provide informed consent may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could lead to improved health management strategies for pregnant women with autoimmune diseases and better outcomes for their infants.
How similar studies have performed: Other studies focusing on the impact of autoimmune diseases during pregnancy have shown promising results, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Durham, North Carolina
- Duke University — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Megan EB Clowse, MD, MPH — Duke Health
- Study coordinator: Laura Neil
- Email: laura.k.neil@duke.edu
- Phone: 919 684 8936
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.