About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Any significant health condition which would cause inability to comply with protocol based on investigator discretion.
History of lung transplantation
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.
Trial population
1. Females aged 16 years or older with CF under the care of the Royal Brompton Hospital adult CF Unit who are planning a pregnancy or pregnant. 2. Biological offspring of people with CF (both mothers and fathers) cared for by the Royal Brompton Hospital Adult CF Service, from birth to aged six years.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Change in FEV1
Change in FEV1 percent predicted (ppFEV1) from pre-conception/baseline to end of pregnancy, and at 12- and 24-months post-partum.
Incidence of CF-related pulmonary complications during pregnancy.
Incidence of premature delivery
Defined as birth \<37 weeks gestation.
Frequency of liver dysfunction in infants
Defined as ALT/AST/GGT/bilirubin above upper limit of normal using laboratory normal ranges. This is prospectively obtained in the 'Mini' sub-study, and retrospectively reviewed from medical records in the 'Midi' sub-study.
Sponsors and contacts
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Royal Brompton & Harefield NHS Foundation Trust
Lead sponsor
Cystic Fibrosis Trust
Collaborator
King's College London
Collaborator
Imperial College London
Collaborator