Study Evaluating Maternal and FetaL Outcomes in the ERA of ModulatorS (MAYFLOWERS)

Brief description of study

The purpose of any research study is to answer questions. The MAYFLOWERS study is being done to look at how pregnancy affects the health of women with cystic fibrosis (CF) and to look at the health of babies born to women with CF. It is expected that most but not all women will be taking the newest CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) modulator medication called TRIKAFTA®. It is not known how this medication will affect the health of the mother and baby. Recruiting pregnant women <=12 weeks

Detailed description of study

The MAYFLOWERS study will: • Collect information about your baseline health in the 2 years before pregnancy using information from your medical records. • Collect information about you, and about your mental and physical health during and after pregnancy including lung function and weight. • Collect information about your pregnancy by reviewing your pregnancy and delivery records. • Collect information about your baby’s health by reviewing your baby’s pediatric records. • Collect information about your baby’s development by asking you specific questions. • Collect blood samples. A portion of the blood collected will be used to determine how much CFTR modulator is present (in those women who are taking them during pregnancy), and a portion will be stored for future research. This is called specimen banking. The MAYFLOWERS study also has an optional part called the Continuous Glucose Monitoring (CGM) sub-study. You can still participate in the MAYFLOWERS core study if you choose not to participate in this optional sub-study. The purpose of the CGM sub-study is to learn more about glucose (blood sugar) levels in pregnant women with CF. CGM tracks and records glucose levels throughout the day and night. A small CGM device will be attached to the back of your arm. It uses a tiny sensor inserted under the skin to check glucose levels while you are wearing it. The information will be used for the MAYFLOWERS study.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions:
Pregnant,Cystic Fibrosis,CFF
Age: Between 18 Years - 50 Years
Gender: Female

Updated on 09 Mar 2024. Study ID: 849674

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