- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03276923
Maternal Autoimmune Disease Research Alliance (MADRA) Registry (MADRA)
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.
Study Overview
Status
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Laura Neil
- Phone Number: 919 684 8936
- Email: laura.k.neil@duke.edu
Study Contact Backup
- Name: Edna Scarlett
- Phone Number: 919-684-6150
- Email: edna.scarlett@duke.edu
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Recruiting
- Duke University
-
Contact:
- Laura Neil
- Phone Number: 919 684 8936
- Email: laura.k.neil@duke.edu
-
Contact:
- Megan Clowse, MD
- Phone Number: 919-681-2045
- Email: megan.clowse@duke.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Maternal Autoimmune Disease ReseArch (MADRA) Registry
Women with autoimmune diseases who are pregnant
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
up to 10 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Megan EB Clowse, MD, MPH, Duke Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Eye Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Stomatognathic Diseases
- Mouth Diseases
- Lacrimal Apparatus Diseases
- Arthritis, Rheumatoid
- Xerostomia
- Salivary Gland Diseases
- Dry Eye Syndromes
- Lupus Erythematosus, Systemic
- Autoimmune Diseases
- Sjogren's Syndrome
Other Study ID Numbers
- Pro00084014
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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