Prospective Study of Pregnancy in Women With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

— MAYFLOWERS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04828382
• Other study ID #: MAYFLOWERS-OB-20
• Status: Recruiting
• Start date: September 30, 2021
• Est. completion date: December 30, 2026

Study information

• Verified date: December 2023
• Source: Seattle Children's Hospital
• Contact: Natallia Cameron, MS
• Phone: 206-884-7550
• Email: natallia.cameron[@]seattlechildrens.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 285
• Est. completion date: December 30, 2026
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Pregnancy Related

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	John Hopkins Hospital	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Saint Luke's Cystic Fibrosis Center of Idaho	Boise	Idaho
United States	Boston Children's Hospital, Brigham & Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	The Cystic Fibrosis Center of Western New York	Buffalo	New York
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	Cleveland Clinic Cystic Fibrosis Program	Cleveland	Ohio
United States	Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	University of Texas Southwestern	Dallas	Texas
United States	National Jewish Health	Denver	Colorado
United States	University of Florida	Gainesville	Florida
United States	Helen DeVos Children's Hospital	Grand Rapids	Michigan
United States	Joe DiMaggio Children's Hospital	Hollywood	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	Indiana University Medical Center	Indianapolis	Indiana
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of California San Diego	La Jolla	California
United States	University of Kentucky	Lexington	Kentucky
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Center for Cystic Fibrosis at Keck Medical Center of USC	Los Angeles	California
United States	University of Wisconsin	Madison	Wisconsin
United States	Froedtert & Medical College of Wisconsin	Milwaukee	Wisconsin
United States	The Minnesota Cystic Fibrosis Center	Minneapolis	Minnesota
United States	Vanderbilt Children's Hospital	Nashville	Tennessee
United States	Tulane University	New Orleans	Louisiana
United States	Columbia University Cystic Fibrosis Program	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Oregon Health Sciences University	Portland	Oregon
United States	University of Rochester Medical Center Strong Memorial	Rochester	New York
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Intermountain Cystic Fibrosis Center	Salt Lake City	Utah
United States	University of Washington Medical Center	Seattle	Washington
United States	SUNY Upstate Medical University	Syracuse	New York

Sponsors (4)

Lead Sponsor	Collaborator
Amalia Magaret	Cystic Fibrosis Foundation, National Jewish Health, University of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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