Pregnancy Outcomes Study for Lupus and Antiphospholipid Syndrome
Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)
Recruiting
Observational Study
Systemic Lupus Erythematosus
Antiphospholipid Syndrome
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 – 45
- Sex
- Female
- Study type
- Observational
- Participants needed
- 700 (estimated)
- Sponsor
- Hospital for Special Surgery, New York · Other
Who this trial is looking for
This trial is looking for pregnant women with systemic lupus erythematosus or antiphospholipid syndrome to understand how certain proteins may affect pregnancy outcomes. Participants will be monitored throughout their pregnancy to see if these proteins can predict complications.
Are You a Good Fit for This Trial?
You may be able to join if
- I am pregnant with a live intrauterine pregnancy.
- I am between 18 and 45 years old, or under 18 with parental consent.
- My hematocrit is greater than 26%.
- I have certain antibody test results indicating antiphospholipid syndrome.
- I have had at least one successful pregnancy if I am a control subject.
- I have no history of fetal death or more than one miscarriage.
- I am not a smoker.
- I have no medical problems requiring chronic treatment.
You may not be able to join if
- I have diabetes mellitus.
- I have a known or suspected hereditary complement deficiency.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
The PROMISSE Study is an observational study of 700 pregnant patients, enrolled at nine major clinical centers. The purpose of the study is 1) to determine whether certain proteins (called complement split products) that can injure healthy organs can be used to predict poor pregnancy outcome in patients with systemic lupus erythematosus (SLE) and anti-phospholipid syndrome (APS), and/or 2) to dete…
Trial Locations
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Eligibility Criteria
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 c…
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