RecruitingOBSERVATIONAL

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.

At a glance

Status

Recruiting

Sponsor

Hospital for Special Surgery, New York

Enrolment target

700

Start

01 Sep 2003

Estimated completion

01 Mar 2027

Systemic Lupus Erythematosus Antiphospholipid Syndrome

What is this study about?

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.

Key takeaways

A study for pregnant women with Lupus or Antiphospholipid Syndrome.
Aims to find early blood markers for pregnancy complications.
Participation involves regular clinic visits and blood tests.
This is an observational study, so no new treatments are given.
Information gathered will help improve future care for other mothers.
You can stop participating at any time.

Who may be eligible?

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'.

Quick self-check

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?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

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.

Potential risks and benefits

Participating in this study might not offer a direct medical benefit to you personally, as it's an observational study focused on gathering information. However, your involvement will be incredibly valuable in helping researchers understand and potentially predict pregnancy complications in women with Lupus or Antiphospholipid Syndrome in the future. This could lead to better care for other mothers. The main risks involve the discomfort of regular blood draws, and there's a small risk of bruising or infection at the needle site. All your medical information will be kept confidential. Remember, you can choose to leave the study at any time without giving a reason, and this will not affect your medical care.

Locations (10)

Northwestern University
Chicago, United States· Completed
University of Chicago
Chicago, United States· Completed
Johns Hopkins Hospital
Baltimore, United States· Completed
NYU Langone Medical Center/Hospital for Joint Diseases
New York, United States· Recruiting
Hospital for Special Surgery
New York, United States· Recruiting
Columbia University Medical Center
New York, United States· Completed
Oklahoma Medical Research Foundation
Oklahoma City, United States· Completed
University of Utah Salt Lake City
Salt Lake City, United States· Recruiting
Mt. Sinai Hospital
Toronto, Canada· Recruiting
Guy's & St Thomas' NHS Foundation Trust
London, United Kingdom· Completed

Common questions

What is Systemic Lupus Erythematosus (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.

How often will I need to visit the clinic?

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.

How to find out more

Marta M. Guerra, MS

guerram@hss.edu 212-774-7361 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.