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Duke Autoimmunity in Pregnancy Registry

Duke Autoimmunity in Pregnancy Registry

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00513591
Acronym
DAP Registry
Enrollment
513
Registered
2007-08-08
Start date
2007-08-31
Completion date
2018-11-19
Last updated
2019-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

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.

Interventions

None listed

Sponsors

Duke University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026