Observing the effects of CFTR modulators in pregnant women with cystic fibrosis and their newborns
Monitoring of Women and Children Exposed to the Combination of Elexacaftor-tezacaftor-ivacaftor During Bregnancy and Through Mother's Own Milk.
This study looks at how CFTR modulators affect pregnant women with cystic fibrosis and their newborns to see if the treatment impacts their health and the babies’ health, including any effects from breast milk.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | N/A to 50 Years |
| Sex | All |
| Sponsor | Region Stockholm Government |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT06302270 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on women with cystic fibrosis who are treated with CFTR modulators during pregnancy and the postpartum period. It aims to register maternal health parameters and assess the effects of CFTR modulators on newborn infants, including any impacts from exposure through breast milk. The study will gather data to better understand the implications of CFTR modulator treatment in this unique population.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women with cystic fibrosis who are being treated with Kaftrio.
Not a fit: Patients who are not pregnant or those with cystic fibrosis not receiving CFTR modulators will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effects of CFTR modulators during pregnancy, potentially improving maternal and infant health outcomes.
How similar studies have performed: While there may be limited data on this specific population, other studies on CFTR modulators have shown promising results in managing cystic fibrosis, indicating potential for success in this observational approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Woman with cystic fibrosis who is pregnant and treated with Kaftrio. Newborn infant to the above mentioned woman Exclusion Criteria: none
Where this trial is running
Stockholm
- Stockholm CF center — Stockholm, Sweden (Recruiting)
Study contacts
- Study coordinator: jenny svedenkrans
- Email: jenny.svedenkrans@regionstockholm.se
- Phone: +46 8 123 80000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.