Summary

Eligibility
for females ages 16 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

Summary

In this study, the investigators aim to evaluate changes in lung function in women with cystic fibrosis (CF) during pregnancy and for 2 years after pregnancy based on exposure to highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators.

Official Title

A Prospective Study Evaluating Maternal and Fetal Outcomes in the Era of Modulators

Details

Advances in medical treatment, including the use of highly effective CFTR modulators have greatly increased life expectancy in women with CF, but the effects of pregnancy on women with CF are yet unknown. It is anticipated that over 90% of the CF population will be on CFTR modulators in the next few years. More knowledge about the effects of CFTR modulators in pregnancy is needed. This is a prospective, multi-center, observational study to follow pregnant women with CF, conducted at 40 US sites. Women are enrolled in the first trimester of pregnancy and assessed every 3 months during pregnancy and during the first year after delivery, then every 6 months for an additional year. Changes in lung function over the course of pregnancy will be evaluated based on cumulative CFTR modulator use while pregnant while accounting for other factors that may influence changes in pulmonary function: baseline lung function, genotype, history of exacerbations, and pre-existing co-morbid conditions.

Keywords

Pregnancy Related Cystic Fibrosis Pregnancy/obstetric health in women with cystic fibrosis Pregnancy CFTR modulators Fibrosis

Eligibility

You can join if…

Open to females ages 16 years and up

  • Pregnant, intending to continue pregnancy, enrolled in the CFF registry

You CAN'T join if...

  • None

Locations

  • University of California San Diego not yet accepting patients
    La Jolla California 92093 United States
  • Center for Cystic Fibrosis at Keck Medical Center of USC not yet accepting patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amalia Magaret
ID
NCT04828382
Study Type
Observational
Last Updated