Multi-resistant Enterobacteriaceae ColonisationEMENCT02631226
Multi-resistant Enterobacteriaceae Colonisation in Less Than 32 Weeks Pregnant Women Admitted to the Hospital.
An observational study of Multi-resistant Enterobacteriaceae Colonisation and Pregnancy, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
The purpose of this study is to determine the prevalence and risk factors for multi-resistant enterobacteriaceae colonization in less than 32 weeks pregnant women admitted to the hospital and its transmission to the newborn, in order to avoid neonatal intensive care unit spread and nosocomial outbreaks. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Multi-resistant Enterobacteriaceae Colonisation, Pregnancy, Nosocomial Outbreaks
- How many people
- 580 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2016to Dec 2017
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Less than 32 weeks pregnant woman admitted to the hospital and her newborn if the mother is a multi-resistant enterobacteriaceae carrier.
Who may be able to join
- Less than 32 weeks pregnant woman
- Admitted to the hospital
Who cannot join
- Screening done after 48 hours of admission
- When delivery occurs before screening is performed
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de Sabadell. Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, 08208
Victoria Aldecoa
About this study
Official title: Multi-resistant Enterobacteriaceae Colonisation in Less Than 32 Weeks Pregnant Women Admitted in the Hospital: a Multicenter Study (EME Study).
The purpose of this study is to determine the prevalence and risk factors for multi-resistant enterobacteriaceae colonization in less than 32 weeks pregnant women admitted to the hospital and its transmission to the newborn, in order to avoid neonatal intensive care unit spread and nosocomial outbreaks.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women colonized by resistant enterobacteria | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of multi-resistant enterobacteriaceae colonisation in less than 32 weeks pregnant women
Measured: 18 months
Secondary outcomes (4)
Prevalence of multi-resistant enterobacteriaceae colonisation of African or Asian pregnant women
Measured: 18 months
Incidence of multi-resistant enterobacteriaceae colonisation of pregnant women admitted to the hospital by preterm premature rupture of membranes (PPROM)
Measured: 18 months
Transmission rate from the colonized woman to the newborn
Measured: 18 months
Number of multi-resisitant enterobacteriacea sepsis in the Neonatal Unit
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startFeb 2016
- Primary completionJul 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multi-resistant Enterobacteriaceae ColonisationStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 580 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victoria Aldecoa-Bilbao, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631226
- Sponsor's protocol ID
- CSPTneonat_2015_01
- Acronym
- EME
- Status last verified
- Feb 2016
- First submitted
- 30 Nov 2015
- Last updated
- 11 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-resistant Enterobacteriaceae Colonisation in Less Than 32 Weeks Pregnant Women Admitted in the Hospital: a Multicenter Study (EME Study).
- ClinicalTrials.gov ID
- NCT02631226
- Acronym / sponsor ID
- EME / CSPTneonat_2015_01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 580 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 16 Dec 2015 (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.
The purpose of this study is to determine the prevalence and risk factors for multi-resistant enterobacteriaceae colonization in less than 32 weeks pregnant women admitted to the hospital and its transmission to the newborn, in order to avoid neonatal intensive care unit spread and nosocomial outbreaks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women colonized by resistant enterobacteria | – | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Less than 32 weeks pregnant woman admitted to the hospital and her newborn if the mother is a multi-resistant enterobacteriaceae carrier.
Key inclusion criteria (2 listed)
- Less than 32 weeks pregnant woman
- Admitted to the hospital
Key exclusion criteria (2 listed)
- Screening done after 48 hours of admission
- When delivery occurs before screening is performed
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
Prevalence of multi-resistant enterobacteriaceae colonisation in less than 32 weeks pregnant women
Time frame: 18 months
4 secondary outcomes
Prevalence of multi-resistant enterobacteriaceae colonisation of African or Asian pregnant women
Time frame: 18 months
Incidence of multi-resistant enterobacteriaceae colonisation of pregnant women admitted to the hospital by preterm premature rupture of membranes (PPROM)
Time frame: 18 months
Transmission rate from the colonized woman to the newborn
Time frame: 18 months
Number of multi-resisitant enterobacteriacea sepsis in the Neonatal Unit
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2016.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multi-resistant Enterobacteriaceae Colonisation and Pregnancy, run by Corporacion Parc Tauli at 1 site in Spain.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 11 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Victoria Aldecoa-Bilbao, M.D. (0034937231010 ext. 29314, valdecoa@tauli.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of multi-resistant enterobacteriaceae colonisation in less than 32 weeks pregnant women (time frame: 18 months). It is what the study was designed to measure, not a finding.
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 11 Feb 2016.