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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorRoyal Brompton & Harefield NHS Foundation Trust

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 3 trial groups
Group A: Mama
Group B: Mini
Group C: Midi

Trial outcomes

Primary outcomes

1

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.

Time frame
9 months
2

Incidence of CF-related pulmonary complications during pregnancy.

Time frame
9 months
3

Incidence of premature delivery

Defined as birth \<37 weeks gestation.

Time frame
3 years
4

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.

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Royal Brompton & Harefield NHS Foundation Trust

Lead sponsor

Cystic Fibrosis Trust

Collaborator

King's College London

Collaborator

Imperial College London

Collaborator