RECRUITING

Maternal Autoimmune Disease Research Alliance (MADRA) Registry

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Maternal Autoimmune Disease Research Alliance (MADRA) Registry

Quick Facts

Study Start:2018-01-01
Study Completion:2027-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03276923

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Desire for pregnancy within 6 months or currently pregnant
  2. * Women with systemic autoimmune disease, including:
  3. * Lupus (systemic lupus erythematosus or cutaneous lupus)
  4. * Antiphospholipid Syndrome or positive antiphospholipid antibodies
  5. * Rheumatoid Arthritis
  6. * Scleroderma (systemic sclerosis)
  7. * Sjogren's Syndrome
  8. * Inflammatory Arthritis (including Psoriatic Arthritis and Ankylosing Spondylitis)
  9. * Undifferentiated Connective Tissue Disease (UCTD)
  10. * Vasculitis
  11. * Myositis (Polymyositis or Dermatomyositis)
  12. * Positive Ro/SSA or La/SSB antibodies
  1. * Unable to speak English
  2. * Unable to provide informed consent
  3. * Unable to travel to Duke University for follow-up visits

Contacts and Locations

Study Contact

Laura Neil
CONTACT
919 684 8936
laura.k.neil@duke.edu
Edna Scarlett
CONTACT
919-684-6150
edna.scarlett@duke.edu

Principal Investigator

Megan EB Clowse, MD, MPH
PRINCIPAL_INVESTIGATOR
Duke Health

Study Locations (Sites)

Duke University
Durham, North Carolina, 27705
United States

Collaborators and Investigators

Sponsor: Duke University

  • Megan EB Clowse, MD, MPH, PRINCIPAL_INVESTIGATOR, Duke Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-01-01
Study Completion Date2027-01-01

Study Record Updates

Study Start Date2018-01-01
Study Completion Date2027-01-01

Terms related to this study

Additional Relevant MeSH Terms

  • Autoimmune Diseases
  • Pregnancy Related
  • Systemic Lupus Erythematosus
  • Cutaneous Lupus
  • Rheumatoid Arthritis
  • Sjogren's Syndrome
  • Scleroderma