Maternal Autoimmune Disease Research Alliance (MADRA) Registry

Duke University

Status

Enrolling

Conditions

Sjogren's Syndrome

Scleroderma

Cutaneous Lupus

Pregnancy Related

Systemic Lupus Erythematosus

Rheumatoid Arthritis

Autoimmune Diseases

Study type

Observational

Funder types

Other

Identifiers

NCT03276923

Pro00084014

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,000 estimated patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

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