RecruitingPHASE2INTERVENTIONAL

IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy

This study, called IMPACT, is testing a new medicine called certolizumab for pregnant women with a blood clotting condition called antiphospholipid syndrome (APS). Women with APS can sometimes have problems during pregnancy, even with standard treatment (heparin and low-dose aspirin). Certolizumab is added to this standard treatment to see if it can help prevent issues like miscarriage or early birth. Researchers believe that inflammation in the placenta might cause these problems, and certolizumab could help calm this inflammation. The study aims to find out if this new approach can lead to more successful pregnancies and healthier babies for women with APS.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

David Ware Branch

Enrolment target

Start

17 May 2017

Estimated completion

01 Dec 2027

High Risk Pregnancy Pregnancy Complications Antiphospholipid Syndrome in Pregnancy Lupus Anticoagulant Disorder

What is this study about?

You're reading about a study called IMPACT, which is looking for ways to improve pregnancy outcomes for women with a condition known as antiphospholipid syndrome (APS). APS is an illness where your body's immune system mistakenly attacks healthy tissues, and it can increase the risk of blood clots. For pregnant women, APS can sometimes lead to difficulties like miscarriage or babies being born too early, often because the placenta doesn't develop as it should.

Currently, the usual treatment for pregnant women with APS involves medications like heparin (a blood thinner) and a low dose of aspirin. While these treatments are very helpful, sometimes they aren't enough, and problems can still occur. Research suggests that inflammation in the placenta might play a big part in these pregnancy complications. Doctors are now exploring if a new medicine, certolizumab, which helps to reduce inflammation, could make a difference.

The IMPACT study wants to see if adding certolizumab to the standard treatment (heparin and aspirin) can lead to more successful pregnancies. Certolizumab specifically targets an inflammatory substance in the body called TNF-alpha, which has been linked to placental problems in studies. The hope is that by blocking this inflammation, certolizumab could help the placenta develop better and reduce the risk of pregnancy complications.

Key takeaways

The study is for pregnant women with antiphospholipid syndrome (APS).
It tests adding a new anti-inflammatory medicine, certolizumab, to standard treatment.
The goal is to improve pregnancy outcomes and reduce complications.
Certolizumab is designed not to pass to the baby.
Regular monitoring of mother and baby will be part of the study.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you would need to be pregnant – specifically, less than 8 weeks along, with a confirmed live embryo. You must also have been diagnosed with antiphospholipid syndrome (APS) and have had specific blood tests (called lupus anticoagulant, or LAC) that were positive on more than one occasion. Your age needs to be between 18 and 40 years old, and you would need to be well enough to understand and agree to take part.

There are also some reasons why you might not be able to join. For example, if you have high blood pressure, are pregnant with more than one baby (like twins), or have diabetes before pregnancy. Certain other health conditions, specific medication doses for other illnesses, or a history of or current serious infections like tuberculosis, HIV, or hepatitis would also mean you couldn't participate. Your medical team would check all these details carefully.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you pregnant and less than 8 weeks along?
Have you been diagnosed with antiphospholipid syndrome (APS)?
Have you had positive 'lupus anticoagulant' blood tests more than once?
Are you between 18 and 40 years old?
Do you have any conditions like high blood pressure, diabetes before pregnancy, or current serious infections?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medication, certolizumab, in addition to your usual treatment of heparin and low-dose aspirin. The certolizumab is given through injections. You would have regular appointments to monitor your health and your baby's development, including blood tests and scans. Researchers will compare your pregnancy outcomes to those of women with APS from a previous study who received standard treatment. The total duration of your participation would cover your pregnancy and some follow-up after birth.

Potential risks and benefits

Taking part in any study has potential benefits and risks. The potential benefit here is that adding certolizumab might improve your pregnancy outcomes compared to standard treatment alone. Certolizumab is a medicine that reduces inflammation and doesn't cross the placenta, which means it's not expected to reach your baby. However, like all medicines, it can have side effects. Your study team will explain these in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Hospital for Special Surgery
Verified postcode
New York, United States· Recruiting
University of Utah
Verified postcode
Salt Lake City, United States· Recruiting
TRIO Advancing Reproductive Care
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is antiphospholipid syndrome (APS)?

APS is an immune condition where your body incorrectly makes antibodies that can cause blood clots, which can sometimes lead to complications during pregnancy.

What is certolizumab?

Certolizumab is a medicine that helps reduce inflammation in the body. In this study, it's being tested to see if it can improve how the placenta develops during pregnancy for women with APS.

Will my baby receive certolizumab?

No, certolizumab is specially designed not to cross the placenta, meaning it should not reach your baby.

What kind of monitoring will I have?

You'll have regular check-ups, blood tests, and ultrasound scans to monitor both your health and your baby's growth and development throughout the pregnancy.

Can I stop taking part in the study?

Yes, you are free to leave the study at any time, for any reason, and your decision will not affect your medical care.

How to find out more

Rose Peckham

rose.peckham@hsc.utah.edu 801-585-7617 Official trial record

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