Duke Autoimmunity in Pregnancy Registry (DAP Registry)

October 21, 2019 updated by: Duke University

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

513

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women with autoimmune disease.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1
Women with lupus
2
Health women who are matched to women with lupus by age and race
3
Women with other autoimmune diseases

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Megan E. B. Clowse, MD, MPH, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

November 19, 2018

Study Completion (Actual)

November 19, 2018

Study Registration Dates

First Submitted

August 6, 2007

First Submitted That Met QC Criteria

August 7, 2007

First Posted (Estimate)

August 8, 2007

Study Record Updates

Last Update Posted (Actual)

October 23, 2019

Last Update Submitted That Met QC Criteria

October 21, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00000756

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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