RecruitingOBSERVATIONAL

A Study of Females With CF Throughout Pregnancy and Post-partum, and Follow up of Their Offspring

This study, called 'MATRIARCH_CF', aims to understand the health of women with cystic fibrosis (CF) who are planning a pregnancy, are pregnant, or have recently become mothers. Researchers also want to learn about the health of their babies and young children. This is important because new CF treatments mean more women with CF are having children. The study will look at physical and mental health using various tests and interviews. The goal is to create new guidelines to help families and medical teams make decisions about pregnancy and care for children when a parent has CF. This study is observational, meaning it won't change your medical treatment.

At a glance

Status

Recruiting

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Enrolment target

Start

12 Jun 2025

Estimated completion

01 May 2028

Cystic Fibrosis (CF)Pregnancy Infant, Newborn Exposure During Pregnancy

What is this study about?

This study, called 'MATRIARCH_CF,' is all about understanding the journey of women with cystic fibrosis (CF) through pregnancy and early motherhood, as well as the health of their children. Treatments for CF have improved a lot recently, especially with new medicines called CFTR modulators. These improvements mean that more women with CF are able to consider having children. Because of these advances, doctors and researchers want to learn more about how pregnancy affects women with CF and how their children grow up.

The main goal is to gather detailed information about both the physical health (like how well their lungs work and their nutrition) and their mental well-being during this important time. They also want to check on the health of the babies and young children to see how they are doing. All the information collected will help create better advice and guidelines for CF teams and families. This will make it easier for them to make informed choices about pregnancy and how to best care for children when a parent has CF.

It's important to know that this is an 'observational' study. This means the researchers will watch and collect information without changing any of the medical treatments you are already receiving. You'll continue with your usual care, and the study will simply monitor your health and your child's health with a range of check-ups. Many of these check-ups are optional, giving you some choice in what you take part in.

Key takeaways

The study explores pregnancy and parenthood for women with CF, and child health.
It aims to create better guidelines for families with CF and their healthcare teams.
The study is observational, meaning it won't change your current medical treatment.
It involves detailed health monitoring through various tests and interviews.
Participation includes separate parts for pregnant women ('Mama') and for children aged 0-2 ('Mini') and 3-6 ('Midi').
All participants need to be receiving care at the Royal Brompton Hospital CF service.

Who may be eligible?

The study is split into three parts: 'Mama', 'Mini', and 'Midi', each for different groups.

For the 'Mama' part, you might be able to join if you are 16 years or older, have cystic fibrosis, and are receiving care from the Royal Brompton Hospital's CF service for women's health. You should be either planning to get pregnant or already pregnant when you join. You also need to be able to come to the hospital for the required visits and tests. If you've had a lung transplant or have another serious health condition that would stop you from taking part, you wouldn't be able to join this part of the study.

For the 'Mini' and 'Midi' parts, these are for children. 'Mini' is for babies under 12 months, and 'Midi' is for children aged three to six years old. For both of these, one of the biological parents must have cystic fibrosis and be looked after by the Royal Brompton Hospital Adult CF Service. The child's legal guardian would need to agree to them taking part and be able to bring them for visits and tests. If the legal guardian can't give permission, or if the child has a serious health condition that might affect their lungs (for 'Midi'), they would not be able to join.

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 16 years or older and have Cystic Fibrosis (CF)?
Are you planning a pregnancy or currently pregnant?
Do you receive care from the Royal Brompton Hospital's CF team?
For children: Is one biological parent a CF patient at Royal Brompton Hospital?
For children: Is the child aged between birth and six years old?
Are you able to attend appointments at the Royal Brompton Hospital?

Answer every question to see your result.

What does participation involve?

If you join the 'Mama' part of the study, you would have up to eight visits. These visits would involve things like blood tests, checking how well your lungs are working, some scans, and interviews where you'd talk about your experiences. These visits would happen while you are planning a pregnancy, during pregnancy, and for the first 12 to 24 months after your baby is born.

If your baby joins the 'Mini' part, they would have up to four visits over two years, from birth until they are two years old. These visits might include blood tests, sweat tests (which check for CF), and head scans called brain ultrasounds.

For children aged three to six who join the 'Midi' part, there would be up to two visits. These visits might include tests to see how well their lungs are working and a special scan of their lungs called an MRI. For all parts of the study, you'd be asked to attend check-ups at the Royal Brompton Hospital, and the total duration would vary depending on which part of the study you or your child are involved in.

Potential risks and benefits

Taking part in this study could help us learn valuable information that will improve care and guidelines for other families living with CF in the future. The benefits for you or your child might include receiving extra monitoring and check-ups as part of the study. As with all medical tests, there's always a small chance of minor discomfort or risks from blood tests or scans, which the medical team will explain fully. You are free to ask any questions and can choose to leave the study at any time without it affecting your usual hospital care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Royal Brompton Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is the main goal of this study?

The main goal is to understand the health of women with CF during pregnancy and early parenthood, and the health of their children, to create better guidelines for families and doctors.

Who can take part in this study?

This study is for women with CF who are planning a pregnancy or are pregnant, and for their children aged from birth up to six years old. Participants must be cared for by the Royal Brompton Hospital's CF service.

Will I or my child receive any new treatments in this study?

No, this is an 'observational' study, which means researchers will only collect information and will not provide or change any medical treatments you or your child are already receiving.

What kind of tests will be done?

Tests might include blood tests, lung function tests, various scans (like a brain ultrasound or lung MRI), sweat tests for children, and interviews to talk about your experiences.

Where will the study visits take place?

All study visits will take place at the Royal Brompton Hospital.

How to find out more

Amy Downes

a.downes@imperial.ac.uk 020 7352 8121 Official trial record

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