Recruiting

Observational Study

Sponsor:

Duke University

Code:

NCT03276923

Conditions

Autoimmune Diseases

Pregnancy Related

Systemic Lupus Erythematosus

Cutaneous Lupus

Rheumatoid Arthritis

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Autoimmune Diseases

Pregnancy Related

Systemic Lupus Erythematosus

Cutaneous Lupus

Rheumatoid Arthritis

Study ID

NCT03276923

Start date

Jan 1, 2018

Status verified date

Jan, 2026

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

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 Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Maternal Autoimmune Disease ReseArch (MADRA) Registry

Women with autoimmune diseases who are pregnant

Primary outcome measure

  • Risk factors associated with poor pregnancy outcomes as measured by the MADRA-DAP questionnaire. [ Time Frame: up to 10 years ]

Central Contacts and Locations

Central contacts

Laura Neil

919 684 8936laura.k.neil@duke.edu

Edna Scarlett

919-684-6150edna.scarlett@duke.edu

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Megan Clowse, MD

919 681 2045megan.clowse@duke.edu

Laura Neil

919 684 8936laura.k.neil@duke.edu

More Information

Sponsor

Duke University

Last update posted

Jan 8, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-01-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.