Prospective Study of Pregnancy in Women With Cystic Fibrosis
MAYFLOWERS
A Prospective Study Evaluating Maternal and Fetal Outcomes in the Era of Modulators
1 other identifier
observational
285
1 country
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2021
Longer than P75 for all trials
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2021
CompletedFirst Posted
Study publicly available on registry
April 2, 2021
CompletedStudy Start
First participant enrolled
September 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
November 3, 2025
October 1, 2025
5.8 years
March 22, 2021
October 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Forced expiratory volume at one second (FEV1) percent predicted after delivery and restart of modulators
Change in FEV1 percent predicted after delivery and restart of modulators relative to measures assessed prior to pregnancy
42 weeks
Forced expiratory volume at one second (FEV1) percent predicted after delivery
Change in FEV1 percent predicted after delivery relative to measures assessed prior to pregnancy
42 weeks
Eligibility Criteria
Study participants will be recruited at Cystic Fibrosis Foundation's Therapeutics Development Network study sites. Pregnant women appearing for regular clinical care at these participating centers will be approached for enrollment.
You may qualify if:
- Pregnant, intending to continue pregnancy, enrolled in the Cystic Fibrosis Foundation Patient Registry (CFFPR)
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amalia Magaretlead
- University of Texascollaborator
- National Jewish Healthcollaborator
- Cystic Fibrosis Foundationcollaborator
Study Sites (40)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
University of California San Diego
La Jolla, California, 92093, United States
National Jewish Health
Denver, Colorado, 80206, United States
University of Florida
Gainesville, Florida, 32610, United States
Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021, United States
Emory University
Atlanta, Georgia, 30327, United States
Saint Luke's Cystic Fibrosis Center of Idaho
Boise, Idaho, 83702, United States
Indiana University Medical Center
Indianapolis, Indiana, 46202, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Tulane University
New Orleans, Louisiana, 70112, United States
John Hopkins Hospital
Baltimore, Maryland, 21205, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston Children's Hospital, Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49546, United States
The Minnesota Cystic Fibrosis Center
Minneapolis, Minnesota, 55455, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 69198, United States
The Cystic Fibrosis Center of Western New York
Buffalo, New York, 14203, United States
Columbia University Cystic Fibrosis Program
New York, New York, 10032, United States
University of Rochester Medical Center Strong Memorial
Rochester, New York, 14642, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27517, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic Cystic Fibrosis Program
Cleveland, Ohio, 44195, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Oregon Health Sciences University
Portland, Oregon, 97239, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15224, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Vanderbilt Children's Hospital
Nashville, Tennessee, 37232, United States
University of Texas Southwestern
Dallas, Texas, 75390, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Intermountain Cystic Fibrosis Center
Salt Lake City, Utah, 84132, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
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.
PMID: 39666984DERIVED
Biospecimen
Serum, plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raksha Jain, MD
University of Texas
- PRINCIPAL INVESTIGATOR
Jennifer Taylor-Cousar
National Jewish
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of Statistical Research
Study Record Dates
First Submitted
March 22, 2021
First Posted
April 2, 2021
Study Start
September 30, 2021
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
November 3, 2025
Record last verified: 2025-10