MRSA Colonization in Peripartum Women and Their Offspring

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Orlando Regional Medical Center
ClinicalTrials.gov Identifier:
NCT00336427
First received: June 9, 2006
Last updated: NA
Last verified: May 2006
History: No changes posted
  Purpose

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.


Condition
Pregnancy
Bacterial Colonization

Study Type: Observational
Study Design: Allocation: Random Sample
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Official Title: A Prospective Study of MRSA Colonization in Peripartum Women and Their Offspring

Further study details as provided by Orlando Regional Medical Center:

Estimated Enrollment: 600
Study Start Date: September 2005
Estimated Study Completion Date: May 2006
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Singleton pregnancy expected to deliver next 24 hours

Exclusion Criteria:

  • Cesarean sections
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336427

Sponsors and Collaborators
Orlando Regional Medical Center
Pfizer
Investigators
Principal Investigator: Margret G Reusch, MD ORMC
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00336427     History of Changes
Other Study ID Numbers: ORMC-MRSA-Pregnancy
Study First Received: June 9, 2006
Last Updated: June 9, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Orlando Regional Medical Center:
MRSA
Colonization
Pregnancy
Neonates

ClinicalTrials.gov processed this record on August 20, 2014