Duke Autoimmunity in Pregnancy Registry
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Arthritis, Lupus, Rheumatoid Arthritis, Skin and Soft Tissue Infections, Infectious Disease, Women's Studies, Dermatology, Dermatology, Rheumatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Immunology / Infectious Diseases, Rheumatology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/3/2018 |
| Start Date: | August 2007 |
| End Date: | December 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.
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.
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.
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.
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
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