PregnancyNCT00336427
MRSA Colonization in Peripartum Women and Their Offspring
An observational study of Pregnancy and Bacterial Colonization, run by Orlando Regional Medical Center.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Bacterial Colonization
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to May 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Singleton pregnancy expected to deliver next 24 hours
Who cannot join
- Cesarean sections
About this study
Official title: A Prospective Study of MRSA Colonization in Peripartum Women and Their Offspring
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.
Read the 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.
- Conditions
- Pregnancy, Bacterial Colonization
- Keywords
- MRSA, Colonization, Pregnancy, Neonates
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2006 (estimated)
- Study startSep 2005
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Other
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- Orlando Regional Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Margret G Reusch, MD, Principal investigator, ORMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00336427
- Sponsor's protocol ID
- ORMC-MRSA-Pregnancy
- Status last verified
- May 2006
- First submitted
- 9 Jun 2006
- Last updated
- 13 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of MRSA Colonization in Peripartum Women and Their Offspring
- ClinicalTrials.gov ID
- NCT00336427
- Acronym / sponsor ID
- ORMC-MRSA-Pregnancy
- Conditions
- Pregnancy, Bacterial Colonization
- Keywords
- MRSA, Colonization, Pregnancy, Neonates
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- Orlando Regional Medical CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Sep 2005
- Study completion
- May 2006
- First posted
- 13 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Other
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Singleton pregnancy expected to deliver next 24 hours
Key exclusion criteria (1 listed)
- Cesarean sections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margret G Reusch, MD principal investigator
ORMC
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Bacterial Colonization, run by Orlando Regional Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2006.