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.|
|ClinicalTrials.gov Identifier: NCT00513591|
Recruitment Status : Completed
First Posted : August 8, 2007
Last Update Posted : October 23, 2019
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|
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.
|Study Type :||Observational|
|Actual Enrollment :||513 participants|
|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
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 ClinicalTrials.gov identifier (NCT number): NCT00513591
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Megan E. B. Clowse, MD, MPH||Duke University|