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Duke Autoimmunity in Pregnancy Registry (DAP Registry)

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. Read our disclaimer for details. Identifier: NCT00513591
Recruitment Status : Completed
First Posted : August 8, 2007
Last Update Posted : October 23, 2019
Information provided by (Responsible Party):
Duke University

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.

Condition or disease
Pregnancy Systemic Lupus Erythematosus Cutaneous Lupus Rheumatoid Arthritis Sjogren's Syndrome Scleroderma

Detailed Description:

Women with a systemic autoimmune disease that would be followed by a rheumatologist will be included in this study.

All women will be seen every 4-6 weeks throughout pregnancy. At each visit, women will complete a questionnaire, the physician will determine the current level of disease activity, and a blood sample will be taken. For women with lupus and healthy women, and additional visit will occur at the start of the 3rd trimester for a closer evaluation of predictors of preterm birth.

This is not an intervention study. Women will not be given experimental medication. All recommendations for treatment and monitoring will be made based on the best available data with input from the treating obstetrician.

Women in this Registry are not required to be seen by Duke Obstetrics nor to deliver at a Duke Hospital.

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Study Type : Observational
Actual Enrollment : 513 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Duke Autoimmunity in Pregnancy Registry
Study Start Date : August 2007
Actual Primary Completion Date : November 19, 2018
Actual Study Completion Date : November 19, 2018

Women with lupus
Health women who are matched to women with lupus by age and race
Women with other autoimmune diseases

Biospecimen Retention:   Samples With DNA
Blood samples will be collected and stored for future analysis.

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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women with autoimmune disease.

Inclusion Criteria:

  • 18 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

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): NCT00513591

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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
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Principal Investigator: Megan E. B. Clowse, MD, MPH Duke University

Additional Information:
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Responsible Party: Duke University Identifier: NCT00513591     History of Changes
Other Study ID Numbers: Pro00000756
First Posted: August 8, 2007    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
Keywords provided by Duke University:
Lupus (systemic lupus erythematosus or cutaneous lupus)
Rheumatoid Arthritis
Sjogren's Syndrome
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Sjogren's Syndrome
Lupus Erythematosus, Systemic
Scleroderma, Systemic
Scleroderma, Diffuse
Autoimmune Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Immune System Diseases
Skin Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases