CFTR Modulators in Pregnancy and Postpartum

Monitoring of Women and Children Exposed to the Combination of Elexacaftor-tezacaftor-ivacaftor During Bregnancy and Through Mother's Own Milk.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06302270

Enrollment

Registered

2024-03-08

Start date

2024-03-15

Completion date

2039-01-31

Last updated

2024-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Brief summary

Observational study on women with Cystic Fibrosis treated with CFTR modulators during pregnancy and postpartum and their children. Registration on maternal health parameters and effects of CFTR-modulators in the newborn infant as well as effects of exposure through mother's own milk.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 50 Years

Healthy volunteers

Inclusion criteria

Woman with cystic fibrosis who is pregnant and treated with Kaftrio. Newborn infant to the above mentioned woman

Exclusion criteria

none

Design outcomes

Primary

Measure	Time frame
Health effects in the newborn infant	6 years

Countries

Sweden

Contacts

Primary Contactjenny svedenkrans

jenny.svedenkrans@regionstockholm.se+46 8 123 80000

Backup ContactTerezia Pinzikova

+46 8 123 80000

Outcome results