Prospective Study of Pregnancy in Women With Cystic Fibrosis
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cystic Fibrosis
- Pregnancy Related
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 16 years and 125 years
- Gender
- Only males
Description
Advances in medical treatment, including the use of highly effective CFTR modulators have greatly increased life expectancy in women with CF, but the effects of pregnancy on women with CF are yet unknown. It is anticipated that over 90% of the CF population will be on CFTR modulators in the next few...
Advances in medical treatment, including the use of highly effective CFTR modulators have greatly increased life expectancy in women with CF, but the effects of pregnancy on women with CF are yet unknown. It is anticipated that over 90% of the CF population will be on CFTR modulators in the next few years. More knowledge about the effects of CFTR modulators in pregnancy is needed. This is a prospective, multi-center, observational study to follow pregnant women with CF, conducted at 40 US sites. Women are enrolled in the first trimester of pregnancy and assessed every 3 months during pregnancy and during the first year after delivery, then every 6 months for an additional year. Changes in lung function over the course of pregnancy will be evaluated based on cumulative CFTR modulator use while pregnant while accounting for other factors that may influence changes in pulmonary function: baseline lung function, genotype, history of exacerbations, and pre-existing co-morbid conditions.
Tracking Information
- NCT #
- NCT04828382
- Collaborators
- University of Texas
- National Jewish Health
- Cystic Fibrosis Foundation
- Investigators
- Principal Investigator: Raksha Jain, MD University of Texas Principal Investigator: Jennifer Taylor-Cousar National Jewish
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