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Studies

Observational Recruiting

NCT06797206 on ClinicalTrials.gov

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

Official title: An Observational Study to Evaluate the Impact of Pregnancy and Parenthood in Females With Cystic Fibrosis and Their Offspring in the CFTR Modulator Era.

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

Primary Outcome Measures

  • Change in FEV1 (9 months)
    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. (9 months)
  • Incidence of premature delivery (3 years)
    Defined as birth \<37 weeks gestation.
  • Frequency of liver dysfunction in infants (2 years)
    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.
  • Incidence of congential abnormalities (3 years)
    Based on medical history and examination
  • Frequency of CF diagnoses in infants despite negative newborn screen testing (3 years)
    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).
  • Frequency of abnormal lung clearance index results in young children (3 years)
    A lung clearance index (LCI) measurement above the normal levels as defined by investigating laboratory values (Midi only)

Countries

United Kingdom

Locations and Investigators

  • Royal Brompton Hospital, London, United Kingdom (Recruiting)
    • Amy Downes
    • Idan Bokobza

Study Officials

  • Imogen Felton (Principal Investigator) — Royal Brompton Hospital and NHLI Imperial College London
  • Jane Davies (Principal Investigator) — Royal Brompton Hospital and NHLI Imperial College London