Registry for pregnant women with autoimmune diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.