Multi-resistant Enterobacteriaceae Colonisation in Less Than 32 Weeks Pregnant Women Admitted to the Hospital. (EME)

February 10, 2016 updated by: Victoria Aldecoa-Bilbao, Corporacion Parc Tauli

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

580

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Recruiting
        • Hospital de Sabadell. Corporació Sanitària Parc Taulí
        • Contact:
          • Victoria Aldecoa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Less than 32 weeks pregnant woman admitted to the hospital and her newborn if the mother is a multi-resistant enterobacteriaceae carrier.

Description

Inclusion Criteria:

  • Less than 32 weeks pregnant woman
  • Admitted to the hospital

Exclusion Criteria:

  • Screening done after 48 hours of admission
  • When delivery occurs before screening is performed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Pregnant women colonized by resistant enterobacteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of multi-resistant enterobacteriaceae colonisation in less than 32 weeks pregnant women
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevalence of multi-resistant enterobacteriaceae colonisation of African or Asian pregnant women
Time Frame: 18 months
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
18 months
Transmission rate from the colonized woman to the newborn
Time Frame: 18 months
18 months
Number of multi-resisitant enterobacteriacea sepsis in the Neonatal Unit
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

November 30, 2015

First Submitted That Met QC Criteria

December 11, 2015

First Posted (Estimate)

December 16, 2015

Study Record Updates

Last Update Posted (Estimate)

February 11, 2016

Last Update Submitted That Met QC Criteria

February 10, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • CSPTneonat_2015_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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