Maternal Autoimmune Disease Research Alliance (MADRA) Registry
MADRA
1 other identifier
observational
1,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2017
CompletedFirst Posted
Study publicly available on registry
September 8, 2017
CompletedStudy Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
January 8, 2026
January 1, 2026
9 years
August 29, 2017
January 6, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Risk factors associated with poor pregnancy outcomes as measured by the MADRA-DAP questionnaire.
The investigators will ask the participants questions from the MADRA-DAP questionnaire to determine poor pregnancy outcomes.
up to 10 years
Study Arms (1)
Maternal Autoimmune Disease ReseArch (MADRA) Registry
Women with autoimmune diseases who are pregnant
Eligibility Criteria
Women who have been diagnosed with an autoimmune disease or a rheumatic condition.
You 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 may not qualify if:
- Unable to speak English
- Unable to provide informed consent
- Unable to travel to Duke University for follow-up visits
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Duke University
Durham, North Carolina, 27705, United States
Biospecimen
Blood and urine samples will be collected.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Megan EB Clowse, MD, MPH
Duke Health
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 100 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2017
First Posted
September 8, 2017
Study Start
January 1, 2018
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
January 8, 2026
Record last verified: 2026-01