Duke Autoimmunity in Pregnancy Registry (DAP Registry)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00513591
First received: August 6, 2007
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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
Pregnancy
Systemic Lupus Erythematosus
Cutaneous Lupus
Rheumatoid Arthritis
Sjogren's Syndrome
Scleroderma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Duke Autoimmunity in Pregnancy Registry

Resource links provided by NLM:


Further study details as provided by Duke University:

Biospecimen Retention:   Samples With DNA

Blood samples will be collected and stored for future analysis.


Estimated Enrollment: 200
Study Start Date: August 2007
Groups/Cohorts
1
Women with lupus
2
Health women who are matched to women with lupus by age and race
3
Women with other autoimmune diseases

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women with autoimmune disease.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00513591

Contacts
Contact: Megan E. B. Clowse, MD, MPH 919-681-2045 megan.clowse@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Megan E. B. Clowse, MD, MPH    919-681-2045    megan.clowse@duke.edu   
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Megan E. B. Clowse, MD, MPH Duke University
  More Information

Additional Information:
No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00513591     History of Changes
Other Study ID Numbers: Pro00000756
Study First Received: August 6, 2007
Last Updated: May 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Pregnancy
Lupus (systemic lupus erythematosus or cutaneous lupus)
Rheumatoid Arthritis
Sjogren's Syndrome
Scleroderma

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Lupus Erythematosus, Systemic
Scleroderma, Diffuse
Scleroderma, Systemic
Sjogren's Syndrome
Syndrome
Autoimmune Diseases
Connective Tissue Diseases
Disease
Dry Eye Syndromes
Eye Diseases
Immune System Diseases
Joint Diseases
Lacrimal Apparatus Diseases
Mouth Diseases
Musculoskeletal Diseases
Pathologic Processes
Rheumatic Diseases
Salivary Gland Diseases
Skin Diseases
Stomatognathic Diseases
Xerostomia

ClinicalTrials.gov processed this record on October 20, 2014