DAP Registry: Duke Autoimmunity in Pregnancy Registry

Sponsor

Duke University (Other)

Overall Status

Completed

CT.gov ID

NCT00513591

Collaborator

(none)

513

Enrollment

Location

135.6

Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Systemic Lupus Erythematosus Cutaneous Lupus Rheumatoid Arthritis Sjogren's Syndrome Scleroderma

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 Design

Study Type:

Observational

Actual Enrollment :

513 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Duke Autoimmunity in Pregnancy Registry

Study Start Date :

Aug 1, 2007

Actual Primary Completion Date :

Nov 19, 2018

Actual Study Completion Date :

Nov 19, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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