Maternal Autoimmune Disease Research Alliance (MADRA) Registry (MADRA)
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|ClinicalTrials.gov Identifier: NCT03276923|
Recruitment Status : Recruiting
First Posted : September 8, 2017
Last Update Posted : November 8, 2018
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.
|Condition or disease|
|Autoimmune Diseases Pregnancy Related Systemic Lupus Erythematosus Cutaneous Lupus Rheumatoid Arthritis Sjogren's Syndrome Scleroderma|
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1000 participants|
|Target Follow-Up Duration:||100 Years|
|Official Title:||Maternal Autoimmune Disease Research Alliance (MADRA) Registry|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||January 1, 2027|
|Estimated Study Completion Date :||January 1, 2027|
Maternal Autoimmune Disease ReseArch (MADRA) Registry
Women with autoimmune diseases who are pregnant
- 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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03276923
|Contact: Laura Neil||919 684 email@example.com|
|Contact: Edna Scarlettfirstname.lastname@example.org|
|Principal Investigator:||Megan EB Clowse, MD, MPH||Duke University Health System|