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New study tracks lung function in pregnant women with cystic fibrosis

NCT ID NCT04828382

Knowledge-focused Sponsor: Amalia Magaret Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 285 pregnant women with cystic fibrosis to see how CFTR modulators affect lung function during and after pregnancy. Researchers will measure breathing capacity before, during, and up to two years after delivery. The goal is to better understand how these medications impact both mother and baby.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CFTR modulators
What this could lead to
If successful, this study could help doctors better manage cystic fibrosis treatment during pregnancy to protect both mother and baby.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly test new therapies. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 285 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2021

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Study participants will be recruited at Cystic Fibrosis Foundation's Therapeutics Development Network study sites. Pregnant women appearing for regular clinical care at these participating centers will be approached for enrollment.

Ages

16 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Pregnant, intending to continue pregnancy, enrolled in the Cystic Fibrosis Foundation Patient Registry (CFFPR) Exclusion Criteria: * None

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Conditions

The condition(s) this trial relates to.

cystic fibrosis pregnancy disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cystic fibrosis Pregnancy related

Contacts and locations

Locations

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Boston Children's Hospital, Brigham & Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Cleveland Clinic Cystic Fibrosis Program

    Cleveland, Ohio, 44195, United States

  • Columbia University Cystic Fibrosis Program

    New York, New York, 10032, United States

  • Emory University

    Atlanta, Georgia, 30327, United States

  • Froedtert & Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Helen DeVos Children's Hospital

    Grand Rapids, Michigan, 49546, United States

  • Indiana University Medical Center

    Indianapolis, Indiana, 46202, United States

  • Intermountain Cystic Fibrosis Center

    Salt Lake City, Utah, 84132, United States

  • Joe DiMaggio Children's Hospital

    Hollywood, Florida, 33021, United States

  • John Hopkins Hospital

    Baltimore, Maryland, 21205, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • National Jewish Health

    Denver, Colorado, 80206, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Oregon Health Sciences University

    Portland, Oregon, 97239, United States

  • Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • SUNY Upstate Medical University

    Syracuse, New York, 13210, United States

  • Saint Luke's Cystic Fibrosis Center of Idaho

    Boise, Idaho, 83702, United States

  • The Cystic Fibrosis Center of Western New York

    Buffalo, New York, 14203, United States

  • The Minnesota Cystic Fibrosis Center

    Minneapolis, Minnesota, 55455, United States

  • Tulane University

    New Orleans, Louisiana, 70112, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205, United States

  • University of California San Diego

    La Jolla, California, 92093, United States

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267, United States

  • University of Florida

    Gainesville, Florida, 32610, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Kentucky

    Lexington, Kentucky, 40536, United States

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 69198, United States

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27517, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15224, United States

  • University of Rochester Medical Center Strong Memorial

    Rochester, New York, 14642, United States

  • University of Texas Southwestern

    Dallas, Texas, 75390, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

  • University of Wisconsin

    Madison, Wisconsin, 53792, United States

  • Vanderbilt Children's Hospital

    Nashville, Tennessee, 37232, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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