RecruitingNCT06797206

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

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

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Enrollment

60 participants

Start Date

Jun 12, 2025

Study Type

OBSERVATIONAL

Conditions

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

Summary

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

Eligibility

Inclusion Criteria17

'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 Criteria9

'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

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.