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

• Conditions: Multi-resistant Enterobacteriaceae Colonisation; Nosocomial Outbreaks; Pregnancy

• Registration Number: NCT02631226
• Lead Sponsor: Corporacion Parc Tauli

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-30
• Study First Submitted QC: 2015-12-11
• Study First Posted: 2015-12-16
• Status Verified: 2016-02
• Study Start: 2016-02
• Last Update Submitted: 2016-02-10
• Last Update Posted: 2016-02-11
• Primary Completion: 2017-07
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 580

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of multi-resistant enterobacteriaceae colonisation in less than 32 weeks pregnant women	18 months

Secondary Outcome Measures

Name	Time	Method
Incidence of multi-resistant enterobacteriaceae colonisation of pregnant women admitted to the hospital by preterm premature rupture of membranes (PPROM)	18 months
Transmission rate from the colonized woman to the newborn	18 months
Prevalence of multi-resistant enterobacteriaceae colonisation of African or Asian pregnant women	18 months
Number of multi-resisitant enterobacteriacea sepsis in the Neonatal Unit	18 months

Trial Locations

Locations (1)

Hospital de Sabadell. Corporacio Sanitaria Parc Tauli; 🇪🇸 Sabadell, Barcelona, Spain