MATRIARCH_CF - Mama, Mini and Midi
Research type
Research Study
Full title
Maternal, Infant, Reproductive & Child Health in Cystic Fibrosis - MATRIARCH_CF. An observational study to evaluate the impact of pregnancy and parenthood in females with Cystic Fibrosis and their offspring in the CFTR modulator era.
IRAS ID
352398
Contact name
Imogen Felton
Contact email
Sponsor organisation
Royal Brompton and Harefield Hospitals part of GSTT
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
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 we will not provide or change any treatment. Instead, we will monitor participant’s health, with a range of investigations, all 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.
REC name
HSC REC A
REC reference
25/NI/0027
Date of REC Opinion
19 Mar 2025
REC opinion
Further Information Favourable Opinion