Duke Autoimmunity in Pregnancy Registry

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.

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Key information

Conditions

Pregnancy Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Cutaneous Lupus Dry Eye Syndromes Eye Diseases Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Lupus Erythematosus, Systemic Mouth Diseases Musculoskeletal Diseases Rheumatic Diseases Rheumatoid Arthritis Salivary Gland Diseases Scleroderma Scleroderma, Diffuse Scleroderma, Systemic Sjogren's Syndrome Skin Diseases Skin and Connective Tissue Diseases Stomatognathic Diseases Systemic Lupus Erythematosus Xerostomia

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Acronym: DAP Registry

Important dates

Study start: 2007
Primary completion: 2018
Study completion: 2018
First posted: Aug 8, 2007
Registry last updated: Oct 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed