Maternal Autoimmune Disease Research Alliance (MADRA) Registry

Recruiting

• Conditions: Sjogren's Syndrome; Pregnancy Related; Systemic Lupus Erythematosus; Cutaneous Lupus; Rheumatoid Arthritis; Scleroderma; Autoimmune Diseases

• Registration Number: NCT03276923
• Lead Sponsor: Duke University

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.

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 Timeline

• Study First Submitted: 2017-08-29
• Study First Submitted QC: 2017-09-07
• Study First Posted: 2017-09-08
• Study Start: 2018-01-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-29
• Primary Completion: 2027-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1000

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

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Exclusion Criteria

• Unable to speak English
• Unable to provide informed consent
• Unable to travel to Duke University for follow-up visits

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States