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Active, Not Recruiting

NCT Number: NCT04828382

Prospective Study of Pregnancy in Women With Cystic Fibrosis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pregnancy Related Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

16 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Amalia Magaret

Other

Collaborators

  • Cystic Fibrosis Foundation
  • National Jewish Health
  • University of Texas

Registry information

Official study title

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

Acronym: MAYFLOWERS

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Apr 2, 2021
Registry last updated
Nov 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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