Pregnancy RelatedMAYFLOWERSNCT04828382
Prospective Study of Pregnancy in Women With Cystic Fibrosis
An observational study of Pregnancy Related and Cystic Fibrosis, run by Amalia Magaret at 40 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Pregnancy Related, Cystic Fibrosis
- How many people
- 285 participants
- Where
- 40 sitesUnited States
- Study dates
- 30 Sep 2021to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- Pregnant, intending to continue pregnancy, enrolled in the Cystic Fibrosis Foundation Patient Registry (CFFPR)
Who cannot join
- None
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30327
John Hopkins Hospital
Baltimore, Maryland, 21205
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Saint Luke's Cystic Fibrosis Center of Idaho
Boise, Idaho, 83702
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Children's Hospital, Brigham & Women's Hospital
Boston, Massachusetts, 02115
The Cystic Fibrosis Center of Western New York
Buffalo, New York, 14203
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27517
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic Cystic Fibrosis Program
Cleveland, Ohio, 44195
Nationwide Children's Hospital
Columbus, Ohio, 43205
University of Texas Southwestern
Dallas, Texas, 75390
National Jewish Health
Denver, Colorado, 80206
University of Florida
Gainesville, Florida, 32610
Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49546
Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
Baylor College of Medicine
Houston, Texas, 77030
Indiana University Medical Center
Indianapolis, Indiana, 46202
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of California San Diego
La Jolla, California, 92093
University of Kentucky
Lexington, Kentucky, 40536
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
University of Wisconsin
Madison, Wisconsin, 53792
Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
The Minnesota Cystic Fibrosis Center
Minneapolis, Minnesota, 55455
Vanderbilt Children's Hospital
Nashville, Tennessee, 37232
Tulane University
New Orleans, Louisiana, 70112
Columbia University Cystic Fibrosis Program
New York, New York, 10032
University of Nebraska Medical Center
Omaha, Nebraska, 69198
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15224
Oregon Health Sciences University
Portland, Oregon, 97239
University of Rochester Medical Center Strong Memorial
Rochester, New York, 14642
Intermountain Cystic Fibrosis Center
Salt Lake City, Utah, 84132
University of Washington Medical Center
Seattle, Washington, 98195
Washington University School of Medicine
St Louis, Missouri, 63110
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
Official title: A Prospective Study Evaluating Maternal and Fetal Outcomes in the Era of Modulators
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.
Read the 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.
- Conditions
- Pregnancy Related, Cystic Fibrosis
- Keywords
- Pregnancy/obstetric health in women with cystic fibrosis, Pregnancy, CFTR modulators, Cystic Fibrosis
- Medical subject headings
- Cystic Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 42 weeks
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
Measured: 42 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start30 Sep 2021
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 285 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amalia Magaret
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas, National Jewish Health, Cystic Fibrosis Foundation
- Responsible party
- Sponsor-investigator, Amalia Magaret, Seattle Children's Hospital
- Investigators
- Raksha Jain, MD, Principal investigator, University of TexasJennifer Taylor-Cousar, Principal investigator, National Jewish
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828382
- Sponsor's protocol ID
- MAYFLOWERS-OB-20
- Acronym
- MAYFLOWERS
- Status last verified
- Oct 2025
- First submitted
- 22 Mar 2021
- Last updated
- 3 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Goralski JL, Talati AN, Hardisty EE, Vora NL. Pregnancy in People With Cystic Fibrosis Treated With Highly Effective Modulator Therapy. Obstet Gynecol. 2025 Jan 1;145(1):47-54. doi: 10.1097/AOG.0000000000005732. Epub 2024 Sep 19.
PubMed 39666984
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Evaluating Maternal and Fetal Outcomes in the Era of Modulators
- ClinicalTrials.gov ID
- NCT04828382
- Acronym / sponsor ID
- MAYFLOWERS / MAYFLOWERS-OB-20
- Conditions
- Pregnancy Related, Cystic Fibrosis
- Keywords
- Pregnancy/obstetric health in women with cystic fibrosis, Pregnancy, CFTR modulators, Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 285 participants (estimated)
- Lead sponsor
- Amalia MagaretUniversity, hospital or other
- Collaborators
- University of Texas, National Jewish Health, Cystic Fibrosis Foundation
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 2 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- Pregnant, intending to continue pregnancy, enrolled in the Cystic Fibrosis Foundation Patient Registry (CFFPR)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
- Derived from this study: PubMed 39666984Goralski JL, Talati AN, Hardisty EE, Vora NL. Pregnancy in People With Cystic Fibrosis Treated With Highly Effective Modulator Therapy. Obstet Gynecol. 2025 Jan 1;145(1):47-54. doi: 10.1097/AOG.0000000000005732. Epub 2024 Sep 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raksha Jain, MD principal investigator
University of Texas
Jennifer Taylor-Cousar principal investigator
National Jewish
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Cystic Fibrosis, run by Amalia Magaret at 40 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced expiratory volume at one second (FEV1) percent predicted after delivery and restart of modulators (time frame: 42 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04828382, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2025.