Prospective Study of Pregnancy in Women with Cystic Fibrosis
- Conditions
- Cystic FibrosisPregnancy Related
- Registration Number
- NCT04828382
- Lead Sponsor
- Amalia Magaret
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 285
- Pregnant, intending to continue pregnancy, enrolled in the Cystic Fibrosis Foundation Patient Registry (CFFPR)
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Forced expiratory volume at one second (FEV1) percent predicted after delivery and restart of modulators 42 weeks Change in FEV1 percent predicted after delivery and restart of modulators relative to measures assessed prior to pregnancy
Forced expiratory volume at one second (FEV1) percent predicted after delivery 42 weeks Change in FEV1 percent predicted after delivery relative to measures assessed prior to pregnancy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (40)
The Minnesota Cystic Fibrosis Center
🇺🇸Minneapolis, Minnesota, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
University of California San Diego
🇺🇸La Jolla, California, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Joe DiMaggio Children's Hospital
🇺🇸Hollywood, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Saint Luke's Cystic Fibrosis Center of Idaho
🇺🇸Boise, Idaho, United States
Indiana University Medical Center
🇺🇸Indianapolis, Indiana, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Tulane University
🇺🇸New Orleans, Louisiana, United States
John Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Boston Children's Hospital, Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
Helen DeVos Children's Hospital
🇺🇸Grand Rapids, Michigan, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
The Cystic Fibrosis Center of Western New York
🇺🇸Buffalo, New York, United States
Columbia University Cystic Fibrosis Program
🇺🇸New York, New York, United States
University of Rochester Medical Center Strong Memorial
🇺🇸Rochester, New York, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Cystic Fibrosis Program
🇺🇸Cleveland, Ohio, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Vanderbilt Children's Hospital
🇺🇸Nashville, Tennessee, United States
University of Texas Southwestern
🇺🇸Dallas, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Intermountain Cystic Fibrosis Center
🇺🇸Salt Lake City, Utah, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Froedtert & Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States