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New registry aims to unlock secrets of autoimmune disease in pregnancy

NCT ID NCT03276923

Knowledge-focused Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This registry enrolls pregnant women or those planning pregnancy who have autoimmune diseases like lupus or rheumatoid arthritis. Researchers at Duke University will track health data to find ways to improve outcomes for mothers and babies. The goal is to better understand risk factors and guide future treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2018

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Women who have been diagnosed with an autoimmune disease or a rheumatic condition.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

ankylosing spondylitis antiphospholipid syndrome autoimmune disease cutaneous lupus erythematosus dermatomyositis diffuse scleroderma polymyositis pregnancy disorder psoriatic arthritis rheumatoid arthritis scleroderma Sjogren syndrome systemic lupus erythematosus systemic sclerosis undifferentiated connective tissue syndrome vasculitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autoimmune diseases Cutaneous lupus Pregnancy related Rheumatoid arthritis Scleroderma Sjogren's syndrome Systemic lupus erythematosus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Duke University

    RECRUITING

    Durham, North Carolina, 27705, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.