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Duke Autoimmunity in Pregnancy Registry (DAP Registry)

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ClinicalTrials.gov Identifier: NCT00513591
Recruitment Status : Active, not recruiting
First Posted : August 8, 2007
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
Duke University

August 6, 2007
August 8, 2007
October 1, 2018
August 2007
December 2019   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00513591 on ClinicalTrials.gov Archive Site
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Duke Autoimmunity in Pregnancy Registry
Duke Autoimmunity in Pregnancy Registry

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Blood samples will be collected and stored for future analysis.
Non-Probability Sample
Pregnant women with autoimmune disease.
  • Pregnancy
  • Systemic Lupus Erythematosus
  • Cutaneous Lupus
  • Rheumatoid Arthritis
  • Sjogren's Syndrome
  • Scleroderma
Not Provided
  • 1
    Women with lupus
  • 2
    Health women who are matched to women with lupus by age and race
  • 3
    Women with other autoimmune diseases
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
513
200
December 2019
December 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00513591
Pro00000756
No
Not Provided
Not Provided
Duke University
Duke University
Not Provided
Principal Investigator: Megan E. B. Clowse, MD, MPH Duke University
Duke University
September 2018