MADRA Registry for Autoimmune Diseases and Pregnancy

The Maternal Autoimmune Disease Research Alliance (MADRA) Registry is an observational study for women with autoimmune diseases who are planning to become pregnant or are currently pregnant. This registry aims to understand how autoimmune conditions like lupus (systemic lupus erythematosus or cutaneous lupus), rheumatoid arthritis, and others affect pregnancy outcomes. Researchers will collect information from your regular doctor visits during pregnancy and up to 12 months after delivery. The goal is to identify risk factors that lead to poor pregnancy outcomes, measured by a questionnaire called MADRA-DAP, over a period of up to 10 years. This study does not involve new medications or procedures beyond your usual care.

Study design
This is an observational study, meaning it collects information without testing new treatments. It plans to enroll 1000 women.
What's involved
You would continue your standard medical care with your rheumatologist and obstetrician. Data from your office visits during pregnancy and up to 12 months after delivery will be collected.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, risk factors associated with poor pregnancy outcomes, will be measured at up to 10 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03276923

Maternal Autoimmune Disease Research Alliance (MADRA) Registry

Recruiting
Not specifiedAll AgesObservational
Duke University
~1,000 participants
Updated 2026-01-08 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Risk factors associated with poor pregnancy outcomes as measured by the MADRA-DAP questionnaire.
Measured over up to 10 years
Autoimmune Diseases
Pregnancy Related
Systemic Lupus Erythematosus
Cutaneous Lupus
Rheumatoid Arthritis
Sjogren's Syndrome
Scleroderma
1 sites across 1 states
North Carolina1
  • Megan EB Clowse, MD, MPH · PRINCIPAL_INVESTIGATOR · Duke Health

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Unable to speak English
Unable to provide informed consent
Unable to travel to Duke University for follow-up visits
  • Risk factors associated with poor pregnancy outcomes as measured by the MADRA-DAP questionnaire.up to 10 years

    The investigators will ask the participants questions from the MADRA-DAP questionnaire to determine poor pregnancy outcomes.