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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04828382
Other study ID # MAYFLOWERS-OB-20
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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