RECRUITING
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Maternal Autoimmune Disease Research Alliance (MADRA) Registry
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.
Conditions:
🦠 Autoimmune Diseases 🦠 Pregnancy Related 🦠 Systemic Lupus Erythematosus 🦠 Cutaneous Lupus 🦠 Rheumatoid Arthritis 🦠 Sjogren's Syndrome 🦠 Scleroderma
🗓️ Study Start (Actual) 1 January 2018
🗓️ Primary Completion (Estimated) 1 January 2027
✅ Study Completion (Estimated) 1 January 2027
👥 Enrollment (Estimated) 1000
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Durham, North Carolina, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 29 August 2017
  • First Submitted that Met QC Criteria 7 September 2017
  • First Posted 8 September 2017

Study Record Updates

  • Last Update Submitted that Met QC Criteria 25 January 2024
  • Last Update Posted 29 January 2024
  • Last Verified January 2024
I'm interested ...!!