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New study seeks early warning signs for pregnancy complications in lupus patients

NCT ID NCT00198068

Knowledge-focused Sponsor: Hospital for Special Surgery, New York 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 observational study is following 700 pregnant women with lupus or antiphospholipid syndrome across nine medical centers. Researchers are looking at specific proteins in the blood to see if they can predict serious pregnancy complications like fetal death, preterm delivery, or low birth weight. The goal is to find early markers that could help doctors manage these high-risk pregnancies better.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors identify high-risk pregnancies early and improve monitoring for women with lupus or antiphospholipid syndrome.
What could go wrong
This is an observational study, not a treatment trial. It may not lead to direct changes in care, and results may not apply to all patients.

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 700 people

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

Start date

Sep 2003

Expected to finish

Mar 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

Pregnant patients identified by investigators at each study site

Ages

18 to 45 years

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: * Patient pregnant with live intrauterine pregnancy, as defined by positive test for elevated β-HCG, but ≤ 12 weeks by gestation (for subjects without aPL antibodies) and ≤18 weeks (for subjects with aPL antibodies) * Patient between the ages of 18-45 and able to give informed consent, or age \< 18 years with parental consent * Hematocrit \> 26% * For APL positive: * aCL: IgG \>= 40 GPL units; IgM \>= 40 MPL units * Positive LAC (RVVT, Kaolin, dilute TTI or PTT LA) * Anti-β2GPI: IgG \>= 40 GPL units; IgM \>= 40 MPL units * For control subjects: * At least one successful pregnancy * No history of fetal death (death of conceptus ≥ 10 weeks' gestation) * No more than 1 miscarriage \< 10 weeks' gestation * No history of positive aPL in local lab or positive aPL in core labs at screening * Not currently a smoker * No medical problems requiring chronic treatment Exclusion Criteria: * Diabetes mellitus (Type I and Type II) antedating pregnancy * Known or suspected hereditary complement deficiency (defined by CH50 = 0)

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Conditions

The condition(s) this trial relates to.

antiphospholipid syndrome systemic lupus erythematosus

As listed by the trial registrant

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

Antiphospholipid 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

    4 sites in 2 countries. 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

  • Columbia University Medical Center

    COMPLETED

    New York, New York, 10032, United States

  • Guy's & St Thomas' NHS Foundation Trust

    COMPLETED

    London, SE1 7EH, United Kingdom

  • Hospital for Special Surgery

    RECRUITING

    New York, New York, 10021, United States

  • Johns Hopkins Hospital

    COMPLETED

    Baltimore, Maryland, 21287, United States

  • Mt. Sinai Hospital

    RECRUITING

    Toronto, Ontario, M5G 2K4, Canada

  • NYU Langone Medical Center/Hospital for Joint Diseases

    RECRUITING

    New York, New York, 10016, United States

  • Northwestern University

    COMPLETED

    Chicago, Illinois, 60611, United States

  • Oklahoma Medical Research Foundation

    COMPLETED

    Oklahoma City, Oklahoma, 73104, United States

  • University of Chicago

    COMPLETED

    Chicago, Illinois, 60637, United States

  • University of Utah Salt Lake City

    RECRUITING

    Salt Lake City, Utah, 84132, United States

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