Prospective Study of Pregnancy in Women With Cystic Fibrosis (MAYFLOWERS)

October 30, 2025 updated by: Amalia Magaret

A Prospective Study Evaluating Maternal and Fetal Outcomes in the Era of Modulators

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.

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

285

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • La Jolla, California, United States, 92093
        • University of California San Diego
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Hollywood, Florida, United States, 33021
        • Joe DiMaggio Children's Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30327
        • Emory University
    • Idaho
      • Boise, Idaho, United States, 83702
        • Saint Luke's Cystic Fibrosis Center of Idaho
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Medical Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • John Hopkins Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital, Brigham & Women's Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System
      • Grand Rapids, Michigan, United States, 49546
        • Helen DeVos Children's Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • The Minnesota Cystic Fibrosis Center
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Nebraska
      • Omaha, Nebraska, United States, 69198
        • University of Nebraska Medical Center
    • New York
      • Buffalo, New York, United States, 14203
        • The Cystic Fibrosis Center of Western New York
      • New York, New York, United States, 10032
        • Columbia University Cystic Fibrosis Program
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center Strong Memorial
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • University of North Carolina at Chapel Hill
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati Medical Center
      • Cleveland, Ohio, United States, 44106
        • Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Cystic Fibrosis Program
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health Sciences University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • University of Pittsburgh Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Children's Hospital
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Intermountain Cystic Fibrosis Center
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert & Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced expiratory volume at one second (FEV1) percent predicted after delivery and restart of modulators
Time Frame: 42 weeks
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
Time Frame: 42 weeks
Change in FEV1 percent predicted after delivery relative to measures assessed prior to pregnancy
42 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amalia Magaret

Collaborators

University of Texas
Cystic Fibrosis Foundation
National Jewish Health

Investigators

  • Principal Investigator: Raksha Jain, MD, University of Texas
  • Principal Investigator: Jennifer Taylor-Cousar, National Jewish

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2021

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

March 22, 2021

First Submitted That Met QC Criteria

March 31, 2021

First Posted (Actual)

April 2, 2021

Study Record Updates

Last Update Posted (Estimated)

November 3, 2025

Last Update Submitted That Met QC Criteria

October 30, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAYFLOWERS-OB-20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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