Maternal Autoimmune Disease Research Alliance (MADRA) Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Autoimmune Diseases, Pregnancy Related, Systemic Lupus Erythematosus, Cutaneous Lupus. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Risk factors associated with poor pregnancy outcomes as measured by the MADRA-DAP questionnaire. [Time frame: up to 10 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Duke University — Durham
Identifiers
NCT: NCT03276923 · Pro00084014