Prospective Study of Pregnancy in Women With Cystic Fibrosis
Purpose
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.
Conditions
- Pregnancy Related
- Cystic Fibrosis
Eligibility
- Eligible Ages
- Over 16 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Pregnant, intending to continue pregnancy, enrolled in the Cystic Fibrosis Foundation Patient Registry (CFFPR)
Exclusion Criteria
- None
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Recruiting Locations
Birmingham, Alabama 35294
Little Rock, Arkansas 72205
La Jolla, California 92093
Los Angeles, California 90033
Boise, Idaho 83702
Kansas City, Kansas 66160
Boston, Massachusetts 02114
Boston, Massachusetts 02115
Ann Arbor, Michigan 48109
Grand Rapids, Michigan 49546
Minneapolis, Minnesota 55455
Saint Louis, Missouri 63110
Omaha, Nebraska 69198
Buffalo, New York 14203
New York, New York 10032
Rochester, New York 14642
Chapel Hill, North Carolina 27517
Cincinnati, Ohio 45267
Cleveland, Ohio 44106
Columbus, Ohio 43205
Philadelphia, Pennsylvania 19104
Pittsburgh, Pennsylvania 15224
Charleston, South Carolina 29425
Nashville, Tennessee 37232
Dallas, Texas 75390
Salt Lake City, Utah 84132
Seattle, Washington 98195
Madison, Wisconsin 53792
Milwaukee, Wisconsin 53226
More Details
- NCT ID
- NCT04828382
- Status
- Recruiting
- Sponsor
- Amalia Magaret
Detailed Description
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.