Maternal and FetaL Outcomes in the ERa of ModulatorS
C
Cynthia Brown, MD
Primary Investigator
Enrolling By Invitation
16-100 years
Female
Phase
N/A
285 participants needed
2 Locations
Brief description of study
To characterize changes in FEV1 over the course of pregnancy based on cumulative CFTR modulator use while pregnant along with defining other factors that may influence changes in pulmonary function
Detailed description of study
This is a prospective, multi-center, observational study to follow pregnant women with CF and their infants who are exposed to highly effective CFTR modulators, but will also include unexposed pregnant mothers with CF and their infants. The women will be followed over the course of pregnancy and 2 years post-delivery. The infants will also be followed for 2 years after delivery.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: pregnancy, cystic fibrosis
-
Age: Between 16 Years - 100 Years
-
Gender: Female
Inclusion Criteria:
- Must be ≥ 16 years of age at Enrollment visit.
- B. Currently pregnant (i.e., either positive in-home pregnancy test with an absence of negative confirmatory pregnancy test or positive in-clinic pregnancy test).
- C. Planning to continue with pregnancy.
Exclusion Criteria:
- Participants who fail to meet one or more of the eligibility criteria will not be enrolled in this study. Waivers of any of the above study entry criteria will not be granted.
Updated on
01 Aug 2024.
Study ID: 11628; MAYFLOWERS-OB-20
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