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Trial record 1 of 1 for:    NCT00336427
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MRSA Colonization in Peripartum Women and Their Offspring

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ClinicalTrials.gov Identifier: NCT00336427
Recruitment Status : Completed
First Posted : June 13, 2006
Last Update Posted : June 13, 2006
Sponsor:
Collaborator:
Pfizer
Information provided by:
Orlando Regional Medical Center

Tracking Information
First Submitted Date June 9, 2006
First Posted Date June 13, 2006
Last Update Posted Date June 13, 2006
Study Start Date September 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title MRSA Colonization in Peripartum Women and Their Offspring
Official Title A Prospective Study of MRSA Colonization in Peripartum Women and Their Offspring
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 Type Observational
Study Design Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Pregnancy
  • Bacterial Colonization
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment
 (submitted: June¬†9,¬†2006)
600
Original Enrollment Same as current
Study Completion Date May 2006
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • Singleton pregnancy expected to deliver next 24 hours

Exclusion Criteria:

  • Cesarean sections
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00336427
Other Study ID Numbers ORMC-MRSA-Pregnancy
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Orlando Regional Medical Center
Collaborators Pfizer
Investigators
Principal Investigator: Margret G Reusch, MD ORMC
PRS Account Orlando Regional Medical Center
Verification Date May 2006