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.
Conditions:
🦠 Pregnancy Related 🦠 Cystic Fibrosis
🗓️ Study Start (Actual) 30 September 2021
🗓️ Primary Completion (Estimated) 30 December 2026
✅ Study Completion (Estimated) 30 December 2026
👥 Enrollment (Estimated) 285
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Birmingham, Alabama, United States
📍 Little Rock, Arkansas, United States
📍 La Jolla, California, United States
📍 Los Angeles, California, United States
📍 Denver, Colorado, United States
📍 Gainesville, Florida, United States
📍 Hollywood, Florida, United States
📍 Atlanta, Georgia, United States
📍 Boise, Idaho, United States
📍 Indianapolis, Indiana, United States
📍 Kansas City, Kansas, United States
📍 Lexington, Kentucky, United States
📍 New Orleans, Louisiana, United States
📍 Baltimore, Maryland, United States
📍 Boston, Massachusetts, United States
📍 Boston, Massachusetts, United States
📍 Ann Arbor, Michigan, United States
📍 Grand Rapids, Michigan, United States
📍 Minneapolis, Minnesota, United States
📍 Saint Louis, Missouri, United States
📍 Omaha, Nebraska, United States
📍 Buffalo, New York, United States
📍 New York, New York, United States
📍 Rochester, New York, United States
📍 Syracuse, New York, United States
📍 Chapel Hill, North Carolina, United States
📍 Cincinnati, Ohio, United States
📍 Cleveland, Ohio, United States
📍 Cleveland, Ohio, United States
📍 Columbus, Ohio, United States
📍 Portland, Oregon, United States
📍 Philadelphia, Pennsylvania, United States
📍 Pittsburgh, Pennsylvania, United States
📍 Charleston, South Carolina, United States
📍 Nashville, Tennessee, United States
📍 Dallas, Texas, United States
📍 Houston, Texas, United States
📍 Salt Lake City, Utah, United States
📍 Seattle, Washington, United States
📍 Madison, Wisconsin, United States
📍 Milwaukee, Wisconsin, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

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

    Exclusion Criteria:

    • * None
Ages Eligible for Study: 16 Years to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ 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 Registration Dates

  • First Submitted 22 March 2021
  • First Submitted that Met QC Criteria 31 March 2021
  • First Posted 2 April 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 12 December 2023
  • Last Update Posted 13 December 2023
  • Last Verified December 2023