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

Recruiting now

Conditions studied: Cystic Fibrosis (CF), Pregnancy, Infant, Newborn, Exposure During Pregnancy

In brief

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

Key facts

Study ID

NCT06797206

Run by

Royal Brompton & Harefield NHS Foundation Trust

People needed

60

Starts

2025-06-12

Expected to finish

2028-05-01

Last updated by the study team

2025-10-01

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• '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.

You may not qualify if…

• '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 is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.