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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 : November 8, 2018
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date August 29, 2017
First Posted Date September 8, 2017
Last Update Posted Date November 8, 2018
Actual Study Start Date January 1, 2018
Estimated Primary Completion Date January 1, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 7, 2017)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03276923 on Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Maternal Autoimmune Disease Research Alliance (MADRA) Registry
Official Title Maternal Autoimmune Disease Research Alliance (MADRA) Registry
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.

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 Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 100 Years
Biospecimen Retention:   Samples With DNA
Blood and urine samples will be collected.
Sampling Method Probability Sample
Study Population Women who have been diagnosed with an autoimmune disease or a rheumatic condition.
  • Autoimmune Diseases
  • Pregnancy Related
  • Systemic Lupus Erythematosus
  • Cutaneous Lupus
  • Rheumatoid Arthritis
  • Sjogren's Syndrome
  • Scleroderma
Intervention Not Provided
Study Groups/Cohorts Maternal Autoimmune Disease ReseArch (MADRA) Registry
Women with autoimmune diseases who are pregnant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 7, 2017)
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 1, 2027
Estimated Primary Completion Date January 1, 2027   (Final data collection date for primary outcome measure)
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
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contact: Laura Neil 919 684 8936
Contact: Edna Scarlett 919-684-6150
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT03276923
Other Study ID Numbers Pro00084014
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Duke University
Study Sponsor Duke University
Collaborators Not Provided
Principal Investigator: Megan EB Clowse, MD, MPH Duke University Health System
PRS Account Duke University
Verification Date November 2018