Health of women with cystic fibrosis during pregnancy and their young children

An Observational Study to Evaluate the Impact of Pregnancy and Parenthood in Females With Cystic Fibrosis and Their Offspring in the CFTR Modulator Era.

This project will follow women with cystic fibrosis who are planning pregnancy, pregnant, or new parents, and their babies to see how pregnancy and current CF treatments affect maternal physical and mental health and early child health.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Sex: All
• Sponsor: Royal Brompton & Harefield NHS Foundation Trust (Academic / other)
• Locations: 1 site (London)
• Trial ID: NCT06797206 on ClinicalTrials.gov

What this trial studies

MATRIARCH_CF is an observational cohort that follows people with cystic fibrosis through pregnancy and early parenthood and follows their offspring in early life. It comprises three linked sub-studies: 'Mama' (pregnant or planning pregnancy, age 16+), 'Mini' (infants from birth to age 2), and 'Midi' (children age 3–6). Participants undergo scheduled in-person visits for blood tests, lung function, imaging, sweat tests, interviews, and other age-appropriate investigations such as brain ultrasound or lung MRI. The study does not provide experimental treatments but collects detailed health and psychosocial data to inform care models and screening recommendations in the CFTR modulator era.

Who should consider this trial

Good fit: Ideal candidates are people aged 16 or older with confirmed cystic fibrosis who are planning pregnancy or currently pregnant and under Royal Brompton care, and biological offspring (0–6 years) of parents with CF under Royal Brompton care.

Not a fit: People not followed at Royal Brompton, those not pregnant or planning pregnancy, or children outside the enrolled age windows are unlikely to directly benefit from participation.

Why it matters

Potential benefit: If successful, the study could inform clinical guidelines and improve monitoring and care for pregnant people with CF and their children.

How similar studies have performed: Previous observational cohorts have reported pregnancy outcomes in CF, but thorough early-childhood follow-up in the era of CFTR modulators remains limited, so this work is partly novel.

Eligibility criteria

Inclusion Criteria:

'Mama' sub-study:

* Written informed consent 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
* Planning a pregnancy or pregnant at time of recruitment.
* Ability to adhere to the required visits and investigations.

'Mini' sub-study:

* Written informed consent obtained from participant's legal guardian.
* Infants who have one biological parent with a confirmed diagnosis of CF under care of Royal Brompton Hospital Adult CF Service
* Less than 12 months of age at first visit.
* Ability to adhere to the required visits and investigations.

'Midi' sub-study:

* Written informed consent obtained from participant's legal guardian.
* Children who have one biological parent with a confirmed diagnosis of CF who is under the care of Royal Brompton Hospital Adult CF Service.
* Age three to six years at time of visit
* Ability to adhere to the required visits and investigations.

Exclusion Criteria:

'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.
* Mother of infant has significant comorbidities unrelated to CF which could affect infant outcomes based on investigator discretion.

'Midi' sub-study:

* Legal guardians' inability to provide consent to participate in the study.
* A significant health condition which is known to affect lung function or imaging based on investigator discretion

Where this trial is running

London

• Royal Brompton Hospital — London, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Imogen Felton — Royal Brompton Hospital and NHLI Imperial College London
• Study coordinator: Amy Downes

Conditions Cystic Fibrosis; Pregnancy; Infant, Newborn; Exposure During Pregnancy; Pregnancy/obstetric health in women with cystic fibrosis; CFTR modulators