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

NCT06797206 | Recruiting

• 1 other identifier: 352398
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Keywords

Pregnancy/obstetric health in women with cystic fibrosis; Pregnancy; CFTR modulators

Outcome Measures

Primary Outcomes (7)

• 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.

  9 months

• Incidence of CF-related pulmonary complications during pregnancy.

  9 months

• Incidence of premature delivery

  Defined as birth \<37 weeks gestation.

  3 years

• 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.

  2 years

• Incidence of congential abnormalities

  Based on medical history and examination

  3 years

• Frequency of CF diagnoses in infants despite negative newborn screen testing

  The number of participants with normal IRT subsequently diagnosed with CF (based on a combination of CF genetic tests, sweat chloride, and faecal elastase where appropriate).

  3 years

• Frequency of abnormal lung clearance index results in young children

  A lung clearance index (LCI) measurement above the normal levels as defined by investigating laboratory values (Midi only)

  3 years

Study Arms (3)

Mama

Females with Cystic Fibrosis who are pregnant or planning a pregnancy

Mini

Children aged 0-24 months with one biological parent who has a diagnosis of cystic fibrosis

Midi

Children aged 3-6 years with one biological parent who has a diagnosis of cystic fibrosis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

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.

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

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead
• Cystic Fibrosis Trust: collaborator
• King's College London: collaborator
• Imperial College London: collaborator

Study Sites (1)

Royal Brompton Hospital

London, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sputum, serum and urine

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Imogen Felton

  Royal Brompton Hospital and NHLI Imperial College London

  PRINCIPAL INVESTIGATOR

• Jane Davies

  Royal Brompton Hospital and NHLI Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Downes

CONTACT

020 7352 8121; a.downes@imperial.ac.uk

Idan Bokobza

CONTACT

i.bokobza@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 28, 2025
• Study Start: June 12, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

GB (1)