NCT06797206Recruiting
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.
Source: ClinicalTrials.gov · Last updated 1 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 16 Jan 2025
- Start date
- 12 Jun 2025
- Primary completion date
- Apr 2028
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Diseases
- Cystic fibrosis
- NCT number
- NCT06797206
What you commit to
- Study type: Observational
- Planned participants: 60
- From 12 Jun 2025 to the primary completion date, Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any significant health condition which would cause inability to comply with protocol based on investigator discretion.
- History of lung transplantation
- 'Mini' sub-study:
- A significant health condition which is known to affect lung function or imaging based on investigator discretion
Other
- 'Mama' 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.
Who the study is looking for
- '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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Brompton Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.