Grants and Contracts Details
Description
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.
Status | Active |
---|---|
Effective start/end date | 4/1/21 → 2/15/26 |
Funding
- Seattle Childrens Research Institute: $39,914.00
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