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NCT04828382 · ClinicalTrials.gov registry record
Prospective Study of Pregnancy in Women With Cystic Fibrosis
A clinical trial of Cystic Fibrosis and Pregnancy Related, sponsored by Amalia Magaret.
- Active
- Registry status
- 285
- Enrollment target
- 20
- Study locations
NCT04828382: Active study of Cystic Fibrosis and Pregnancy Related, sponsored by Amalia Magaret.
NCT04828382 is a study of Cystic Fibrosis and Pregnancy Related that is active but no longer recruiting, run by Amalia Magaret. The registered enrollment target is 285 participants, above the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (60% higher). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04828382, a study of Cystic Fibrosis and Pregnancy Related, is active but no longer recruiting, sponsored by Amalia Magaret.
- ACTIVE NOT RECRUITING
- Registry status
- 285 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Change in FEV1 percent predicted after delivery and restart of modulators relative to measures assessed prior to pregnancy
Conditions Studied
Study Locations (20)
Florida
- University of Florida - Gainesville
- Joe DiMaggio Children's Hospital - Hollywood
Massachusetts
- Massachusetts General Hospital - Boston
- Boston Children's Hospital, Brigham & Women's Hospital - Boston
Michigan
- University of Michigan Health System - Ann Arbor
- Helen DeVos Children's Hospital - Grand Rapids
Alabama
- University of Alabama at Birmingham - Birmingham
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
California
- University of California San Diego - La Jolla
Colorado
- National Jewish Health - Denver
Georgia
- Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 285 participants |
| Start Date | 2021-09-30 |
| Est. Completion | 2027-06-30 |
What the registry record for NCT04828382 still lists
NCT04828382 is an observational study that tracks outcomes without assigning an intervention. The registered 285 participants enrollment target is mid-sized for trials with a published cap, above the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (60% higher).
The record links to 2 conditions, with Cystic Fibrosis appearing as the primary indexed condition, and to 0 interventions.
NCT04828382 names 20 study sites across 17 states, led by Florida, Massachusetts, Michigan.
Frequently Asked Questions
What is clinical trial NCT04828382 about?
NCT04828382 is a clinical study titled "Prospective Study of Pregnancy in Women With Cystic Fibrosis". 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.
What is the current status of trial NCT04828382?
This trial is currently active not recruiting. The enrollment target is 285 participants. The study started on 2021-09-30. Estimated completion is 2027-06-30.
What conditions does trial NCT04828382 study?
This clinical trial studies the following conditions: Cystic Fibrosis, Pregnancy Related.
Who is sponsoring clinical trial NCT04828382?
This trial is sponsored by Amalia Magaret, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04828382 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04828382's enrollment target sits among peer trials
285 23rd of 169 higher than 147 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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