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Mayflowers-OB-20

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A Prospective Study Evaluating Maternal and FetaL Outcomes in the ERa of ModulatorS (MAYFLOWERS)

  • Sex at Birth: Female
  • Age: Child (Birth - 17), Adult (18 - 64), Older Adult (65+)
  • Accepting Healthy People: No
  • Type: Interventional / Therapeutic
  • Trial Phase: NA
  • Conditions Being Studied: Lung, Cystic Fibrosis (CF)

Study Purpose

This study is being done to understand how lung function changes in women with cystic fibrosis (CF) who take a medication called Trikafta during pregnancy. Lung function will be measured every 3 months during pregnancy and then at intervals over the next two years. Participants will complete questionnaires asking about health status and will have the option of having blood and breast milk samples collected to measure levels of the Trikafta medication in these body fluids.

Who Can Participate

Age: 16 and older

Principal Investigator
Alex Gifford MD
Department/Division
Pulmonology (Pediatrics)

Locations

UH Cleveland Medical Center
11100 Euclid Avenue
Cleveland OH, 44106

  • UH IRB: SITE00001839
  • StudyID: 2022-01050
  • ClinicalTrials.gov: NCT04828382
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