Duke Autoimmunity in Pregnancy Registry

NCT00513591 | Completed

• 1 other identifier: Pro00000756
• Study Type: observational
• Target: 513
• Locations: 1 country
• Sites: 1

Brief Summary

It is difficult to predict how a women with an autoimmune disease will do during pregnancy. Some women will improve, others will worsen. Some pregnancies progress normally and others become very complicated. The Duke Autoimmunity in Pregnancy (DAP) Registry will enroll women with autoimmune diseases, such as lupus, rheumatoid arthritis, scleroderma, and Sjogren's syndrome who wish to become, or already are, pregnant. We will follow these women throughout pregnancy to better understand how their autoimmune disease affects their pregnancy, and vice versa.

Conditions

Pregnancy; Systemic Lupus Erythematosus; Cutaneous Lupus; Rheumatoid Arthritis; Sjogren's Syndrome; Scleroderma

Keywords

Pregnancy; Lupus (systemic lupus erythematosus or cutaneous lupus); Rheumatoid Arthritis; Sjogren's Syndrome; Scleroderma

Study Arms (3)

1

Women with lupus

2

Health women who are matched to women with lupus by age and race

3

Women with other autoimmune diseases

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women with autoimmune disease.

You may qualify if:

• years of age or older
• 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

You may not qualify if:

• Unable to speak English
• Unable to provide informed consent
• Unable to travel to Duke University for follow-up visits

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Links

• The Duke Lupus Clinic website

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected and stored for future analysis.

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Arthritis, Rheumatoid; Sjogren's Syndrome; Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Scleroderma, Systemic; Skin Diseases

Study Officials

• Megan E. B. Clowse, MD, MPH

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2007
• First Posted: August 8, 2007
• Study Start: August 1, 2007
• Primary Completion: November 19, 2018
• Study Completion: November 19, 2018
• Last Updated: October 23, 2019

Record last verified: 2019-10

Locations

US (1)