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Prospective Study of Pregnancy in Women With Cystic Fibrosis (MAYFLOWERS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04828382
Recruitment Status : Recruiting
First Posted : April 2, 2021
Last Update Posted : January 30, 2023
Sponsor:
Collaborators:
University of Texas
National Jewish Health
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Amalia Magaret, Seattle Children's Hospital

Study Description
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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.

Condition or disease
Pregnancy Related Cystic Fibrosis

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
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Study Type : Observational
Estimated Enrollment : 285 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study Evaluating Maternal and Fetal Outcomes in the Era of Modulators
Actual Study Start Date : September 30, 2021
Estimated Primary Completion Date : December 30, 2025
Estimated Study Completion Date : December 30, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
Serum, plasma

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04828382


Contacts
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Contact: Natallia Cameron, MS 206-884-7550 natallia.cameron@seattlechildrens.org
Contact: Anna Mead 206-884-7531 anna.mead@seattlechildrens.org

Locations
Show Show 40 study locations
Sponsors and Collaborators
Amalia Magaret
University of Texas
National Jewish Health
Cystic Fibrosis Foundation
Investigators
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Principal Investigator: Raksha Jain, MD University of Texas
Principal Investigator: Jennifer Taylor-Cousar National Jewish
More Information
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Responsible Party: Amalia Magaret, Director of Statistical Research, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT04828382    
Other Study ID Numbers: MAYFLOWERS-OB-20
First Posted: April 2, 2021    Key Record Dates
Last Update Posted: January 30, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amalia Magaret, Seattle Children's Hospital:
Pregnancy/obstetric health in women with cystic fibrosis
Pregnancy
CFTR modulators
Cystic Fibrosis
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
 Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases