Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336427
Status:
COMPLETED
Last Update Posted:
2006-06-13
First Post:
2006-06-09
Brief Title:
MRSA Colonization in Peripartum Women and Their Offspring
Sponsor:
Orlando Regional Medical Center
Organization:
Orlando Regional Medical Center
Study Overview
Official Title:
A Prospective Study of MRSA Colonization in Peripartum Women and Their Offspring
Status:
COMPLETED
Status Verified Date:
2006-05
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:
None
Brief Summary:
We hypothesize that pregnant women are at baseline risk for carrying community-acquired MRSA but also have frequent contact with healthcare workers which may put them at risk for hospital-acquired MRSA carriage Our study aimed to identify the colonization rate of women in active labor and whether transmission to infants may occur
Detailed Description:
Mothers are at risk for carrying MRSA What this risk is is not known We have seen a dramatic increase in neonatal intensive care unit MRSA infections Could mothers transmit MRSA to their newborns if they are asymptomatic carriers Mothers come into close contact with health care providers often have other children in daycare known risk factor and may have other exposures to MRSA Our study was designed to sample 300 mother-infant pairs to determine whether MRSA carriage is present in asymptomatic women The study consisted of obtaining informed consent then performing a sterile swab of mothers nares and vaginal area then babies nares and umbilicus once the baby was born
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None