Prospective Study of Pregnancy in Women with Cystic Fibrosis

Active, not recruiting

• Conditions: Cystic Fibrosis; Pregnancy Related

• Registration Number: NCT04828382
• Lead Sponsor: Amalia Magaret

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.

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 Timeline

• Study First Submitted: 2021-03-22
• Study First Submitted QC: 2021-03-31
• Study First Posted: 2021-04-02
• Study Start: 2021-09-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 285

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (40)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

University of California San Diego; 🇺🇸 La Jolla, California, United States

National Jewish Health; 🇺🇸 Denver, Colorado, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Joe DiMaggio Children's Hospital; 🇺🇸 Hollywood, Florida, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Saint Luke's Cystic Fibrosis Center of Idaho; 🇺🇸 Boise, Idaho, United States

Indiana University Medical Center; 🇺🇸 Indianapolis, Indiana, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States

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