Prospective Study of Pregnancy in Women with Cystic Fibrosis

Last updated: January 27, 2025
Sponsor: Amalia Magaret
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Cystic Fibrosis

Lung Disease

Scar Tissue

Treatment

N/A

Clinical Study ID

NCT04828382
MAYFLOWERS-OB-20
  • Ages > 16
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pregnant, intending to continue pregnancy, enrolled in the Cystic FibrosisFoundation Patient Registry (CFFPR)

Exclusion

Exclusion Criteria:

  • None

Study Design

Total Participants: 285
Study Start date:
September 30, 2021
Estimated Completion Date:
December 30, 2026

Study 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.

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • University of California San Diego

    La Jolla, California 92093
    United States

    Site Not Available

  • Center for Cystic Fibrosis at Keck Medical Center of USC

    Los Angeles, California 90033
    United States

    Site Not Available

  • National Jewish Health

    Denver, Colorado 80206
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Joe DiMaggio Children's Hospital

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Central Florida Pulmonary Group

    Orlando, Florida 32803
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30327
    United States

    Site Not Available

  • Saint Luke's Cystic Fibrosis Center of Idaho

    Boise, Idaho 83702
    United States

    Site Not Available

  • Indiana University Medical Center

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • University of Kentucky

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Tulane University

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • John Hopkins Hospital

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • Boston Children's Hospital, Brigham & Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • University of Michigan Health System

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Helen DeVos Children's Hospital

    Grand Rapids, Michigan 49546
    United States

    Site Not Available

  • The Minnesota Cystic Fibrosis Center

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • University of Nebraska Medical Center

    Omaha, Nebraska 69198
    United States

    Site Not Available

  • The Cystic Fibrosis Center of Western New York

    Buffalo, New York 14203
    United States

    Site Not Available

  • Columbia University Cystic Fibrosis Program

    New York, New York 10032
    United States

    Site Not Available

  • University of Rochester Medical Center Strong Memorial

    Rochester, New York 14642
    United States

    Site Not Available

  • SUNY Upstate Medical University

    Syracuse, New York 13210
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27517
    United States

    Site Not Available

  • University of Cincinnati Medical Center

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • Cleveland Clinic Cystic Fibrosis Program

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Nationwide Children's Hospital

    Columbus, Ohio 43205
    United States

    Site Not Available

  • Oregon Health Sciences University

    Portland, Oregon 97239
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Vanderbilt Children's Hospital

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • University of Texas Southwestern

    Dallas, Texas 75390
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Intermountain Cystic Fibrosis Center

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • University of Washington Medical Center

    Seattle, Washington 98195
    United States

    Site Not Available

  • University of Wisconsin

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • Froedtert & Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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