700 Participants Needed

Pregnancy Outcomes for Lupus and Antiphospholipid Syndrome

(PROMISSE Trial)

Recruiting at 3 trial locations
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Overseen ByMarta M. Guerra, MS
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Hospital for Special Surgery, New York
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines pregnant patients with systemic lupus erythematosus (SLE) or antiphospholipid syndrome (APS) to determine if certain blood proteins can predict pregnancy complications. The researchers aim to identify whether these proteins signal risks for poor pregnancy outcomes. The study includes women who are pregnant, have SLE or APS, or have had a successful pregnancy without major complications. Participants should not have diabetes or a known complement deficiency. This trial could enhance pregnancy care for women with these conditions by identifying early warning signs. As an unphased study, it seeks to advance understanding and improve care for future pregnancies.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, control subjects should not have medical problems requiring chronic treatment.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to uncover key predictors of pregnancy outcomes for women with Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS). Unlike current treatments that focus on managing symptoms, this observational study seeks to identify factors that could help anticipate pregnancy complications. By gaining a better understanding of these predictors, healthcare providers could potentially tailor more effective and personalized care strategies for pregnant women with these conditions. This could lead to improved health outcomes for both mothers and their babies.

Who Is on the Research Team?

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Jane E. Salmon, M.D.

Principal Investigator

Hospital for Special Surgery, New York

Are You a Good Fit for This Trial?

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)
Hematocrit > 26%
aCL: IgG >= 40 GPL units; IgM >= 40 MPL units
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observational Follow-up

Participants are followed regularly during the course of the pregnancy, collecting medical and obstetrical information as well as serial blood specimens for complement and cytokine assays

Throughout pregnancy

Post-pregnancy Follow-up

Participants are monitored for neonatal outcomes and complications post-delivery

Until neonatal discharge

What Are the Treatments Tested in This Trial?

Interventions

  • Observational Study

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials
257
Recruited
61,800+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials
508
Recruited
1,090,000+