Status:

RECRUITING

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

Lead Sponsor:

Royal Brompton & Harefield NHS Foundation Trust

Collaborating Sponsors:

Cystic Fibrosis Trust

King's College London

Conditions:

Cystic Fibrosis (CF)

Pregnancy

Eligibility:

All Genders

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, an...

Detailed Description

Improvements in treatments for people with CF have meant that more are becoming pregnant. CFTR modulators (CFTRm) are one of these treatments. They work by tackling the underlying cause of CF. These c...

Eligibility Criteria

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

Key Trial Info

Start Date :

June 12 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

May 1 2028

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT06797206

Start Date

June 12 2025

End Date

May 1 2028

Last Update

October 1 2025

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Royal Brompton Hospital

London, United Kingdom