At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Not specified by the sponsor
- How long the study runs
- Study runs about 35 months (dates as stated)
- About the drug or intervention
- Not specified by the sponsor
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- Not specified
- Who
- All
- Number of participants
- 60
- Started
- 2025-06-12
- Last checked
- 2025-09
Plain English Summary
What is this study?
- • Testing a new treatment for cystic fibrosis (cf)
- • Clinical study - 60 participants
- • In this study, investigators aim to study in detail the physical (including nutritional and pulmonary) and mental health of females with cystic fibrosis (CF) planning a pregnancy, during pregnancy, and in the early parenthood period
Who can take part?
- • Adults
- • Diagnosed with cystic fibrosis (cf)
Where?
- • London - Royal Brompton Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
In this study, investigators aim to study in detail the physical (including nutritional and pulmonary) and mental health of females with cystic fibrosis (CF) planning a pregnancy, during pregnancy, and in the early parenthood period. Additionally the health of offspring in infancy and early life will be studied to understand if further screening investigations or clinical care models should be part of clinical guidelines
More detail
Improvements in treatments for people with CF have meant that more are becoming pregnant. CFTR modulators (CFTRm) are one of these treatments. They work by tackling the underlying cause of CF. These changes have created a need and an opportunity for research into the health and experiences of people with CF and their children in the CFTRm era. The study is called 'MATRIARCH\_CF' and includes 3 related sub-studies: 'Mama' is enrolling participants aged 16 years or older with CF under the care of the Royal Brompton Hospital (RBH) adult CF Unit who are planning a pregnancy or pregnant. The aim is to describe the impact of pregnancy and the first 12-24 months of parenthood in females with CF on their physical and psychological health. Investigations in eight visits include blood tests, lung function, imaging, and interviews. 'Mini' is enrolling biological offspring of people with CF (mothers and fathers) cared for by the RBH Adult CF Service, from birth to age two. The aim is to collect information that will allow for assessment of health outcomes in offspring of parents with CF in the short term. There will be up to four visits over two years with investigations including blood tests, sweat tests, and brain ultrasound. 'Midi' explores the same question as 'Mini' but in the longer term for those aged three-to-six. There will be up to two visits, and they include lung function testing and a lung MRI. This study is described as 'observational' as investigators will not provide or change any treatment. Participant's health will be monitored with a range of investigations, many of which are optional. Knowledge gained from this study will be used to create guidelines to help families with CF and their medical teams make decisions around pregnancy and their offspring.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: Not specified
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ visits and investigations
What the study is looking for
- ✓'Mama' sub-study:
- ✓Written agreement to take part obtained from participant.
- ✓Under the care of Royal Brompton Hospital CF Reproductive and Maternal Health Service
- ✓Age 16 years or above at time of recruitment
- ✓Confirmed diagnosis of CF
Who cannot take part
- ✗'Mama' sub-study:
- ✗Any significant health condition which would cause inability to comply with protocol based on investigator discretion.
- ✗History of lung transplantation
- ✗'Mini' sub-study:
- ✗Legal guardians' inability to provide consent to participate in the study.
See the full criteria
Where Is This Study? (1 UK site)
Royal Brompton Hospital
London, United Kingdom
How to Get in Touch
Amy Downes
Sponsor contactCONTACT
Idan Bokobza
Sponsor contactCONTACT