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Maternal Autoimmune Disease Research Alliance (MADRA) Registry (MADRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03276923
Recruitment Status : Recruiting
First Posted : September 8, 2017
Last Update Posted : January 30, 2020
Information provided by (Responsible Party):
Duke University

Brief Summary:

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

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Maternal Autoimmune Disease ReseArch (MADRA) Registry
Women with autoimmune diseases who are pregnant

Primary Outcome Measures :
  1. 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
Blood and urine samples will be collected.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Women who have been diagnosed with an autoimmune disease or a rheumatic condition.

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03276923

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Contact: Laura Neil 919 684 8936
Contact: Edna Scarlett 919-684-6150

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United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27705
Contact: Megan Clowse, MD    919-681-2045   
Contact: Laura Neil    919 684 8936   
Sponsors and Collaborators
Duke University
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Principal Investigator: Megan EB Clowse, MD, MPH Duke University Health System

Additional Information:

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Responsible Party: Duke University Identifier: NCT03276923    
Other Study ID Numbers: Pro00084014
First Posted: September 8, 2017    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mouth Diseases
Dry Eye Syndromes
Sjogren's Syndrome
Lupus Erythematosus, Systemic
Autoimmune Diseases
Joint Diseases
Musculoskeletal Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Connective Tissue Diseases
Immune System Diseases
Salivary Gland Diseases
Stomatognathic Diseases
Lacrimal Apparatus Diseases
Eye Diseases