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

What this Trial Is About

Researchers are studying the physical, nutritional, pulmonary, and mental health of females with cystic fibrosis (CF) who are planning pregnancy, are pregnant, or in early parenthood. They are also examining the health of their children from infancy through early childhood to see if new screening or care methods should be included in clinical guidelines. This observational study focuses on the impact of pregnancy and parenthood in the era of CFTR modulators, treatments that target the cause of CF. The study, called MATRIARCH_CF, includes three related sub-studies: "Mama" follows females with CF aged 16 or older who are planning pregnancy or pregnant, involving up to eight visits with tests like blood work, lung function, imaging, and interviews. "Mini" enrolls biological offspring from birth to age two, with up to four visits including blood tests, sweat tests, and brain ultrasounds. "Midi" studies children aged three to six with up to two visits involving lung function tests and lung MRI. The study does not provide or change treatments but monitors health through these investigations. Participants will attend multiple visits for physical and psychological assessments, including lung function, imaging, and blood tests for mothers, and various tests for children depending on their age group. Researchers will measure outcomes such as lung function changes, pulmonary complications during pregnancy, premature deliveries, liver dysfunction, congenital abnormalities, and CF diagnoses in children. The study aims to gather detailed health information over several years without altering clinical care, lasting up to three years for some outcomes.

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