RecruitingOBSERVATIONAL

Pregnancy Cohort in Multiple Sclerosis (MS)

This study is for women with Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS) who are pregnant or planning to become pregnant. MS often affects women during their childbearing years, and this research aims to understand how pregnancy influences the disease. During the study, doctors will collect information about the pregnancy and monitor the woman's MS symptoms, blood tests, and MRI scans. They want to see how MS changes during and after pregnancy, and how successful the pregnancies are for women with these conditions. By gathering this information, researchers hope to learn more about how MS and pregnancy interact, which could help improve care for women with MS in the future.

At a glance

Status

Recruiting

Sponsor

Charite University, Berlin, Germany

Enrolment target

100

Start

01 Jan 2013

Estimated completion

31 Dec 2026

Multiple Sclerosis (MS)Clinically Isolated Syndrome (CIS)

What is this study about?

This study focuses on understanding how pregnancy affects women who have Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS). MS is a condition that affects the brain and spinal cord, and it often starts when women are young enough to have children. Because of this, it's really important to learn more about how pregnancy influences MS symptoms and a woman's overall health.

Researchers will carefully follow women during their pregnancy and afterwards. They will gather various pieces of information, such as changes in MS symptoms, results from blood tests, and images from MRI scans (which show detailed pictures of the brain and spinal cord). They will also look at how the pregnancies themselves progress and the health of the baby.

The main goal is to see if pregnancy has any specific effects on MS, or if MS can affect the pregnancy. By collecting this detailed information from many women, doctors hope to gain a clearer picture of this relationship. This knowledge is crucial for guiding future medical advice and support for women with MS who are pregnant or considering starting a family, helping them have the healthiest pregnancies possible.

Key takeaways

This study helps us learn how MS and pregnancy affect each other.
It's for women with MS or CIS who are pregnant or planning pregnancy.
Participation involves sharing information from your regular medical appointments.
You won't get new treatments as part of this study.
Your medical care and rights to withdraw are protected.

Who may be eligible?

This study is specifically designed for women aged 18 to 50 years old. To join, you must have a confirmed diagnosis of Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS). You'll also need to be able to understand the study and agree to take part by signing a consent form.

There are certain reasons why someone might not be able to join. For example, if you have other serious health conditions that could interfere with the study results, or if you have something in your body like a pacemaker or certain metal implants that would make having an MRI scan unsafe, you wouldn't be able to participate. Also, if you have an allergy to the dye sometimes used in MRI scans (called gadolinium), you wouldn't be able to join.

Finally, the study cannot include individuals who are dealing with alcohol or drug abuse issues, as this could also affect the study's results and your safety.

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 between 18 and 50 years old?
Do you have a diagnosis of MS or Clinically Isolated Syndrome (CIS)?
Are you able to agree to take part after understanding the study?
Do you have any metal implants or pacemakers that might prevent an MRI scan?
Do you have any other serious health problems that might affect the study?

Answer every question to see your result.

What does participation involve?

As this is an observational study, it means you won't be given any new medications or treatments specifically for the research. Instead, the researchers will collect information during your regular medical care for MS and pregnancy. This will involve gathering data from your routine appointments, which might include discussions about your symptoms, any medication you're taking, blood tests, and MRI scans if they are part of your usual MS monitoring. The study aims to follow you throughout your pregnancy and for a period afterwards to see how your MS changes over time. The exact number of visits or scans will depend on your individual healthcare plan and what your doctors usually recommend for your MS and pregnancy.

Potential risks and benefits

Taking part in this study may help researchers better understand how MS and pregnancy interact, which could benefit future patients. The main risk is the potential for additional time commitment for assessments, although efforts will be made to use information from your routine care. Any medical procedures, such as MRI scans, would only be conducted if they are already part of your standard MS management or pregnancy care, and all safety precautions would be followed. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Charité Universitätsmedizin Berlin
Verified postcode
Berlin, Germany· Recruiting

Common questions

What is Clinically Isolated Syndrome (CIS)?

CIS is the first episode of symptoms, caused by inflammation and damage to the protective layer of nerves, that is typical of multiple sclerosis but does not yet meet the full criteria for an MS diagnosis.

Will I receive new treatment if I join this study?

No, this is an 'observational' study. You will continue to receive your usual medical care and treatment for MS and your pregnancy. Researchers will simply collect information from that care.

Will the study tell me how my pregnancy will turn out?

No, the study cannot predict individual pregnancy outcomes. It aims to collect information from many women to learn more about general patterns and how MS and pregnancy relate.

Do I have to have MRI scans if I join?

Researchers will collect information from MRI scans if they are already part of your routine MS monitoring. You won't have extra scans just for the study unless they are medically necessary for your care.

What if I change my mind after joining?

You are completely free to leave the study at any time, for any reason, without it affecting the quality of your healthcare.

How to find out more

Nadja Siebert, MD

nadja.siebert@charite.de Official trial record

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