MRSA Colonization in Peripartum Women and Their Offspring
NCT00336427
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pregnancy, Bacterial Colonization
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Singleton pregnancy expected to deliver next 24 hours
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Cesarean sections
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Pregnancy, Bacterial ColonizationMRSA Colonization in Peripartum Women and Their Offspring
NCT00336427
Female
0+
years
MULTIPLE SITES
Advanced Information
| 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 |
| |||
| 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 | 600 | |||
| Original Enrollment | Same as current | |||
| Study Completion Date | May 2006 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| 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 |
| |||
| PRS Account | Orlando Regional Medical Center | |||
| Verification Date | May 2006 | |||