Multi-resistant Enterobacteriaceae Colonisation in Less T... | NCT02631226

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

NCT02631226

Sponsor

Corporacion Parc Tauli

Status

Unknown status

Last Update Posted

Feb 11, 2016Estimated

Enrollment

580Estimated

Phase

Not provided

Conditions

Multi-resistant Enterobacteriaceae Colonisation
Pregnancy
Nosocomial Outbreaks

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2016

Primary Completion Date

Jul 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Nov 30, 2015

First Submission Date that Met QC Criteria

Dec 11, 2015

First Posted Date

Dec 16, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2016

Last Update Posted Date

Feb 11, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

580Estimated

Label	Type	Description	Intervention Names
Pregnant women colonized by resistant enterobacteria

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Prevalence of multi-resistant enterobacteriaceae colonisation of African or Asian pregnant women		18 months
Incidence of multi-resistant enterobacteriaceae colonisation of pregnant women admitted to the hospital by preterm premature rupture of membranes (PPROM)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Victoria Aldecoa-Bilbao, M.D.	Contact	0034937231010	29314	valdecoa@tauli.cat

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Sabadell. Corporacio Sanitaria Parc Tauli	Recruiting	Sabadell	Barcelona	08208	Spain

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided