Prospective Study of Pregnancy in Women With Cystic Fibrosis
NCT ID: NCT04828382
Last Updated: 2025-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
285 participants
OBSERVATIONAL
2021-09-30
2027-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
16 Years
FEMALE
No
Sponsors
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University of Texas
OTHER
National Jewish Health
OTHER
Cystic Fibrosis Foundation
OTHER
Amalia Magaret
OTHER
Responsible Party
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Amalia Magaret
Director of Statistical Research
Principal Investigators
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Raksha Jain, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas
Jennifer Taylor-Cousar
Role: PRINCIPAL_INVESTIGATOR
National Jewish
Locations
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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
The Minnesota Cystic Fibrosis Center
Minneapolis, Minnesota, United States
Washington University School of Medicine
St 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
Countries
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References
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Goralski JL, Talati AN, Hardisty EE, Vora NL. Pregnancy in People With Cystic Fibrosis Treated With Highly Effective Modulator Therapy. Obstet Gynecol. 2025 Jan 1;145(1):47-54. doi: 10.1097/AOG.0000000000005732. Epub 2024 Sep 19.
Other Identifiers
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MAYFLOWERS-OB-20
Identifier Type: -
Identifier Source: org_study_id
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