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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: a.downes@imperial.ac.uk
• Phone: 020 7352 8121

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.