Maternal Autoimmune Disease Research Alliance (MADRA) Registry
| Status: | Recruiting |
|---|---|
| Conditions: | Arthritis, Lupus, Rheumatoid Arthritis, Skin and Soft Tissue Infections, Infectious Disease, Women's Studies, Rheumatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Immunology / Infectious Diseases, Rheumatology, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/10/2018 |
| Start Date: | January 1, 2018 |
| End Date: | January 1, 2027 |
| Contact: | Laura Neil |
| Email: | laura.k.neil@duke.edu |
| Phone: | 919 684 8936 |
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.
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.
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.
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.
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
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