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Maternal Autoimmune Disease Research Alliance (MADRA) Registry

Sponsor
Duke University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03276923
Collaborator
(none)
1,000
Enrollment
1
Location
108
Anticipated Duration (Months)
9.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    At each site, the patients will be under the care of the participating rheumatologist and their local obstetrician during the pregnancy. This is a natural-history study and will not include medications, laboratory testing, or procedures outside of the standard of care.

    Management of the rheumatologic disease will be directed based on patient needs by the local rheumatologist and obstetrician. Enrollment in the registry will not dictate specific therapy. The Registry will include data from each office visit during pregnancy and up to 12 months after delivery.

    The registry will be ongoing, with periodic analysis of clinical data samples as specific studies are approved.

    Enrollment in the registry does not significantly increase risks for a patient.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Maternal Autoimmune Disease Research Alliance (MADRA) Registry
    Actual Study Start Date :
    Jan 1, 2018
    Anticipated Primary Completion Date :
    Jan 1, 2027
    Anticipated Study Completion Date :
    Jan 1, 2027

    Arms and Interventions

    Arm Intervention/Treatment
    Maternal Autoimmune Disease ReseArch (MADRA) Registry

    Women with autoimmune diseases who are pregnant

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Duke University Durham North Carolina United States 27705

    Sponsors and Collaborators

    • Duke University

    Investigators

    • Principal Investigator: Megan EB Clowse, MD, MPH, Duke Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT03276923
    Other Study ID Numbers:
    • Pro00084014
    First Posted:
    Sep 8, 2017
    Last Update Posted:
    Feb 24, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Sjogren's Syndrome
    Lupus Erythematosus, Systemic
    Autoimmune Diseases

    Study Results

    No Results Posted as of Feb 24, 2022