Ignite Creation Date:
2024-05-06 @ 3:58 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04828382
Status:
RECRUITING
Last Update Posted:
2023-12-13
First Post:
2021-03-22
Brief Title:
Prospective Study of Pregnancy in Women With Cystic Fibrosis
Sponsor:
Amalia Magaret
Organization:
Seattle Childrens Hospital
Study Overview
Official Title:
A Prospective Study Evaluating Maternal and Fetal Outcomes in the Era of Modulators
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAYFLOWERS
Brief Summary:
In this study the investigators aim to evaluate changes in lung function in women with cystic fibrosis CF during pregnancy and for 2 years after pregnancy based on exposure to highly effective cystic fibrosis transmembrane conductance regulator CFTR modulators
Detailed 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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None