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NCT Number: NCT03276923

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.

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Key information

Conditions

Autoimmune Diseases Arthritis Arthritis, Rheumatoid Connective Tissue Diseases Cutaneous Lupus Dry Eye Syndromes Eye Diseases Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Lupus Erythematosus, Systemic Mouth Diseases Musculoskeletal Diseases Pregnancy Related Rheumatic Diseases Rheumatoid Arthritis Salivary Gland Diseases Scleroderma Scleroderma, Diffuse Scleroderma, Systemic Sjogren's Syndrome Skin Diseases Skin and Connective Tissue Diseases Stomatognathic Diseases Systemic Lupus Erythematosus Xerostomia

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Risk factors associated with poor pregnancy outcomes as measured by the MADRA-DAP questionnaire.

    Time frame: up to 10 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Edna Scarlett

CONTACT

[email protected]

919-684-6150

Laura Neil

CONTACT

[email protected]

919 684 8936

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Acronym: MADRA

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Sep 8, 2017
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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