Clinical trial NCT00513591: Duke Autoimmunity in Pregnancy Registry
Official title: Duke Autoimmunity in Pregnancy Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Systemic Lupus Erythematosus
Cutaneous Lupus
Rheumatoid Arthritis
Sjogren's Syndrome
Scleroderma
Keywords: Pregnancy
Lupus (systemic lupus erythematosus or cutaneous lupus)
Rheumatoid Arthritis
Sjogren's Syndrome
Scleroderma
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2007-08-08
Enrollment: 513
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with autoimmune disease.

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Megan E. B. Clowse, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: