Duke Autoimmunity in Pregnancy Registry (NCT00513591) | Clinical Trial Compass
CompletedNot Applicable
Duke Autoimmunity in Pregnancy Registry
United States513 participantsStarted 2007-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.