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

December 12, 2023 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

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 Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • California
      • La Jolla, California, United States, 92093
      • Los Angeles, California, United States, 90033
    • Colorado
      • Denver, Colorado, United States, 80206
    • Florida
      • Gainesville, Florida, United States, 32610
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Joe DiMaggio Children's Hospital
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30327
    • Idaho
      • Boise, Idaho, United States, 83702
        • Recruiting
        • Saint Luke's Cystic Fibrosis Center of Idaho
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Medical Center
        • Contact:
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University Of Kansas Medical Center
        • Contact:
    • Kentucky
      • Lexington, Kentucky, United States, 40536
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • John Hopkins Hospital
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
      • Boston, Massachusetts, United States, 02115
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
      • Grand Rapids, Michigan, United States, 49546
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • The Minnesota Cystic Fibrosis Center
        • Contact:
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 69198
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • The Cystic Fibrosis Center of Western New York
        • Contact:
      • New York, New York, United States, 10032
      • Rochester, New York, United States, 14642
      • Syracuse, New York, United States, 13210
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
    • Ohio
      • Cincinnati, Ohio, United States, 45267
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Cystic Fibrosis Program
        • Contact:
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
        • Contact:
      • Columbus, Ohio, United States, 43205
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health Sciences University
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Pittsburgh, Pennsylvania, United States, 15224
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37232
    • Texas
      • Dallas, Texas, United States, 75390
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84132
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington Medical Center
        • Contact:
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Froedtert & Medical College of Wisconsin
        • Contact:

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

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)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

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)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

December 1, 2023

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

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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