At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Not specified by the sponsor
- How long the study runs
- Study runs about 282 months (dates as stated)
- About the drug or intervention
- Not specified by the sponsor
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at what might predict how pregnancy turns out for people with systemic lupus erythematosus (SLE, an immune condition) and antiphospholipid syndrome (APS, a blood clotting condition). It is run by the Hospital for Special Surgery in New York. The study is looking at pregnant people up to certain early stages of pregnancy.
Who can take part
- You are pregnant with a live baby in the womb, confirmed by a pregnancy blood test, and no more than 12 weeks pregnant (or no more than 18 weeks if you have antiphospholipid antibodies)
- You are aged 18 to 45 and able to give consent, or under 18 with a parent's consent
- Your haematocrit (a measure of red blood cells) is above 26%
- If you have antiphospholipid antibodies, these must be at certain levels shown by blood tests
- If you are a control (comparison) participant: you have had at least one successful pregnancy, no history of baby loss at 10 weeks or later, no more than one miscarriage before 10 weeks, no history of positive antiphospholipid antibodies, are not a current smoker, and have no health problems needing long-term treatment
Who may not be able to
- You have diabetes (Type 1 or Type 2) that started before the pregnancy
- You have a known or suspected inherited complement deficiency (part of the immune system), shown by a specific blood test result
What taking part involves
- • Not stated — ask the trial team
Time commitment: Number of visits, how long the study lasts, and what taking part involves: not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years to 45 Years
- Who
- Female
- Number of participants
- 700
- Started
- 2003-09
- Last checked
- 2026-03
Plain English Summary
What is this study?
- • Testing a new treatment for systemic lupus erythematosus
- • Clinical study - 700 participants
- • The PROMISSE Study is an observational study of 700 pregnant patients, enrolled at nine major clinical centers
Who can take part?
- • Ages 18 Years to 45 Years
- • Diagnosed with systemic lupus erythematosus
- • Female only
Where?
- • London - Guy's & St Thomas' NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
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 determine whether elevated levels of circulating antiangiogenic factors predict pregnancy complications in patients with aPL antibodies and/or SLE.
More detail
Thrombosis and pregnancy loss are common features of systemic lupus erythematosus (SLE), particularly in the presence of antiphospholipid (aPL) antibodies. The in vivo mechanisms by which aPL antibodies lead to vascular events and, specifically, to recurrent fetal loss are largely unknown. Studies in a mouse model of antiphospholipid antibody syndrome (APS) indicate that in vivo complement activation is necessary for fetal loss caused by aPL antibodies. This study represents an effort to translate these research observations on the potential role of complement activation in the pathogenesis of aPL antibody-mediated pregnancy loss to a clinically relevant human study. In addition, studies in humans and mice have shown 1) that the balance of circulating angiogenic and antiangiogenic factors predicts preeclampsia and fetal growth restriction in healthy women, 2) circulating antiangiogenic factors cause endothelial dysfunction and abnormal placental development in animal models, and 3) complement activation leads to elevated levels of circulating antiangiogenic factors and complement inhibition prevents increased levels of antiangiogenic factors, placental dysfunction and fetal growth restriction in a mouse model of APS. This study will permit testing the hypothesis that, like in healthy women, the balance of circulating angiogenic and antiangiogenic factors predict complications in women with SLE and APS and to translate the findings in animal models into humans. The PROMISSE Study is a prospective observational study that will follow 700 pregnant patients who will be grouped and analyzed according to the presence or absence of aPL antibodies and preexisting SLE. The patients 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. The data obtained will be analyzed and used to identify mechanisms and predictors of poor fetal outcome. We expect that the insights provided through this study will suggest means to prevent, arrest or modify these conditions.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 45 Years
- Who can join: Female only
Biomarkers mentioned
What the study is looking for
- ✓Patient between the ages of 18-45 and able to give agreement to take part, 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)
Who cannot take part
- ✗Diabetes mellitus (Type I and Type II) antedating pregnancy
- ✗Known or suspected hereditary complement deficiency (defined by CH50 = 0)
See the full criteria
Where Is This Study? (1 UK site)
Guy's & St Thomas' NHS Foundation Trust
London SE1 7EH, United Kingdom
How to Get in Touch
Marta M. Guerra, MS
Sponsor contactCONTACT