Pregnancy Outcomes for Lupus and Antiphospholipid Syndrome
(PROMISSE Trial)
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?
Jane E. Salmon, M.D.
Principal Investigator
Hospital for Special Surgery, New York
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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
Post-pregnancy Follow-up
Participants are monitored for neonatal outcomes and complications post-delivery
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
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
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