Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)
The PROMISSE Study is looking at 700 pregnant women, some with Systemic Lupus Erythematosus (SLE) or Antiphospholipid Syndrome (APS), and some without. The main goal is to understand why some women with these conditions have problems during pregnancy, like miscarriages or other complications. Researchers believe that certain proteins in the blood, called 'complement split products,' or other factors, might predict these problems. By regularly collecting blood samples and medical information throughout pregnancy, the study hopes to identify these early warning signs. This could lead to better ways for doctors to predict and potentially prevent pregnancy complications for women with SLE or APS in the future, improving outcomes for both mothers and babies.
במבט חטוף
על מה המחקר הזה?
This study, called PROMISSE, is looking closely at pregnant women, especially those who have conditions like Systemic Lupus Erythematosus (SLE) or Antiphospholipid Syndrome (APS). SLE is an autoimmune disease where the body's immune system mistakenly attacks its own healthy tissues. APS is another immune condition that can make blood clots more likely and is linked to pregnancy complications. The study wants to understand why some women with these conditions have difficulties during pregnancy, such as miscarriages or other problems.
The researchers are particularly interested in two things. First, they want to see if specific proteins in the blood, called 'complement split products,' could act as early warning signs of pregnancy problems. These proteins can sometimes cause harm to healthy parts of the body. Second, they are investigating whether certain other blood factors, linked to how blood vessels grow, might also predict complications. By studying these factors, they hope to find keys to predicting and preventing issues.
Ultimately, this research aims to translate discoveries made in laboratories and animal studies into real-world benefits for people. By understanding these predictors better, doctors might be able to identify pregnant women at higher risk earlier. This knowledge could lead to new ways to support these pregnancies, potentially reducing complications and improving the chances of a healthy baby.
נקודות עיקריות
- A study for pregnant women with Lupus or Antiphospholipid Syndrome.
- Aims to find early blood markers for pregnancy complications.
- ההשתתפות כוללת ביקורים סדירים במרפאה ובדיקות דם.
- This is an observational study, so no new treatments are given.
- Information gathered will help improve future care for other mothers.
- אתה יכול להפסיק להשתתף בכל עת.
מי עשוי להיות זכאי?
This study is designed for women who are pregnant, aged between 18 and 45. You would need to be in the early stages of pregnancy – up to 12 weeks for those without specific antibodies, and up to 18 weeks for those who do have certain antiphospholipid antibodies. To be considered, your blood count (specifically hematocrit) needs to be above a certain level.
If you have antiphospholipid antibodies, you would need to have specific levels of these antibodies in your blood to be included. If you don't have these antibodies and are joining as a comparison, you would need to have had at least one successful pregnancy in the past and no history of certain pregnancy losses or positive antiphospholipid antibody tests. You also shouldn't be a smoker or have any medical issues needing ongoing treatment.
Unfortunately, you wouldn't be able to join if you have diabetes (Type 1 or Type 2) before pregnancy, or if you have a known or suspected inherited problem with your immune system called a 'complement deficiency'.
האם מחקר זה יכול להתאים לך?
ענה על השאלות המהירות הללו כדי לבדוק אם אתה עשוי להיות זכאי. זהו מדריך בלבד — צוות המחקר מקבל את ההחלטה הסופית.
- Are you pregnant with a baby inside your womb?
- Are you aged between 18 and 45?
- Are you within the early stages of pregnancy (up to 12 or 18 weeks)?
- If you're joining as a comparison, have you had a successful pregnancy before?
- Do you not have diabetes that started before your pregnancy?
- Are you willing to have regular blood tests during your pregnancy?
מה כרוך בהשתתפות?
Taking part in this study would involve regular visits to one of the nine main clinical centres throughout your pregnancy. During these visits, the medical team will collect information about your health and your pregnancy. You will also provide blood samples at these regular intervals. These blood samples will be tested for specific proteins and other factors the researchers are interested in. The study is observational, meaning you won't be given any experimental medications; doctors will continue with your usual antenatal care. The specific duration depends on your pregnancy, as you will be followed regularly until delivery and possibly a short time after, allowing researchers to collect crucial information about the outcome.
סיכונים ותועלות פוטנציאליים
מיקומים (10)
- אוניברסיטת נורת'ווסטרןמיקוד מאומתשיקגו, ארצות הברית· הושלם
- אוניברסיטת שיקגומיקוד מאומתשיקגו, ארצות הברית· הושלם
- בית החולים ג'ונס הופקינסמיקוד מאומתבולטימור, ארצות הברית· הושלם
- NYU Langone Medical Center/Hospital for Joint Diseasesמיקוד מאומתניו יורק, ארצות הברית· גיוס
- Hospital for Special Surgeryמיקוד מאומתניו יורק, ארצות הברית· גיוס
- Columbia University Medical Centerמיקוד מאומתניו יורק, ארצות הברית· הושלם
- Oklahoma Medical Research Foundationמיקוד מאומתOklahoma City, United States· הושלם
- University of Utah Salt Lake Cityמיקוד מאומתסולט לייק סיטי, ארצות הברית· גיוס
- Mt. Sinai Hospitalמיקוד מאומתטורונטו, קנדה· גיוס
- Guy's & St Thomas' NHS Foundation Trustמיקוד מאומתלונדון, הממלכה המאוחדת· הושלם
שאלות נפוצות
מהו זאבת אדמנתית מערכתית (SLE)?
SLE, or Lupus, is a long-term condition where your body's immune system mistakenly attacks healthy tissues, which can cause inflammation and damage in various parts of the body.
What is Antiphospholipid Syndrome (APS)?
APS is another immune condition where your body produces unusual antibodies that can make your blood more likely to clot. In pregnancy, it's linked to complications like miscarriages.
Will I receive new treatments in this study?
No, this is an 'observational' study. You will continue to receive your usual medical care, and researchers will simply collect information and blood samples to learn more.
באיזו תדירות אצטרך לבקר במרפאה?
You will have regular visits throughout your pregnancy, but the exact schedule would be discussed with you by the study team.
Who can I contact if I have more questions?
The research team at the clinic where the study is taking place will be able to answer all your questions. Their contact details will be provided if you are interested in joining.
כיצד לגלות עוד
Marta M. Guerra, MS
תמיד התייעץ עם רופא המשפחה או המומחה שלך לפני שתחליט להשתתף במחקר.
מעוניינים להשתתף?
דיון
דיון קהילתי
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