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

A Prospective Study Evaluating Maternal and FetaL Outcomes in the ERa of ModulatorS (MAYFLOWERS) Primary Objective Our primary objective is to characterize any changes in FEV1 after delivery relative to measures assessed prior to pregnancy based on cumulative CFTR modulator use (including no use) while pregnant. We will additionally assess other practices and factors that may influence changes in FEV1, including duration of pre-pregnancy modulator use, baseline FEV1, genotype, history of exacerbations, and pre-existing co- morbid conditions. The incidence of pulmonary exacerbations will also be evaluated similarly. Secondary Objectives The secondary objectives of this study are: • To assess whether any changes that occur in FEV1 over the course of pregnancy are recovered at one and two years post-delivery. • To assess the association of duration of highly effective modulator therapies (HEMT) prior to and during pregnancy on other maternal health and obstetrical outcomes including: 1. Pregnancy-related complications: gestational diabetes, pre-eclampsia, intrauterine growth restriction, glucose intolerance 2. Obstetrical complications: pre-term labor, assisted delivery, C-section (planned vs. unplanned), hemorrhage 3. Maternal weight change over the course of pregnancy 4. CF symptom scores and measures of mental health: Cystic Fibrosis Questionnaire-Revised (CFQ-R), Patient Health Questionnaire Depression Scale (PHQ-8), and Generalized Anxiety Disorder Scale (GAD-7) • To assess whether maternal health and obstetrical outcomes listed 1-3 above are additionally associated with baseline FEV1 or with pre-pregnancy BMI. • To assess whether prenatal care (number of attended visits) is associated with changes in FEV1.