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NCT00336427 Clinical Trial

MRSA Colonization in Peripartum Women and Their Offspring

Pregnancy Clinical Trial

Official title:
A Prospective Study of MRSA Colonization in Peripartum Women and Their Offspring

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00336427
Other study ID # ORMC-MRSA-Pregnancy
Secondary ID
Status Completed
Phase N/A
First received June 9, 2006
Last updated June 9, 2006
Start date September 2005
Est. completion date May 2006

Study information
Verified date May 2006
Source Orlando Regional Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 600
Est. completion date May 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Singleton pregnancy expected to deliver next 24 hours

Exclusion Criteria:

- Cesarean sections

Study Design

Allocation: Random Sample, Primary Purpose: Screening, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Orlando Regional Medical Center Pfizer
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