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NCT02631226 Clinical Trial

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

Pregnancy Clinical Trial

— EME  

Official title:
Multi-resistant Enterobacteriaceae Colonisation in Less Than 32 Weeks Pregnant Women Admitted in the Hospital: a Multicenter Study (EME Study).

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02631226
Other study ID # CSPTneonat_2015_01
Secondary ID
Status Recruiting
Phase N/A
First received November 30, 2015
Last updated February 10, 2016
Start date February 2016
Est. completion date December 2017

Study information
Verified date February 2016
Source Corporacion Parc Tauli
Contact Victoria Aldecoa-Bilbao, M.D.
Phone 0034937231010
Email valdecoa@tauli.cat
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Observational

Clinical 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 580
Est. completion date December 2017
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Spain Hospital de Sabadell. Corporacio Sanitaria Parc Tauli Sabadell Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of multi-resistant enterobacteriaceae colonisation in less than 32 weeks pregnant women 18 months No
Secondary Prevalence of multi-resistant enterobacteriaceae colonisation of African or Asian pregnant women 18 months No
Secondary Incidence of multi-resistant enterobacteriaceae colonisation of pregnant women admitted to the hospital by preterm premature rupture of membranes (PPROM) 18 months No
Secondary Transmission rate from the colonized woman to the newborn 18 months No
Secondary Number of multi-resisitant enterobacteriacea sepsis in the Neonatal Unit 18 months No
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