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Status unknownNCT02631226EMEUpdated Feb 11, 2016

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

An observational study in Multi-resistant Enterobacteriaceae Colonisation, Pregnancy and Nosocomial Outbreaks, sponsored by Corporacion Parc Tauli. Status unknown at 1 site in Spain. Open to female participants. Per ClinicalTrials.gov, last updated 2016-02-11.

Sponsored by Corporacion Parc Tauli · Observational

The sponsor has not verified this record recently (last verified Feb 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
580
Sex
Female
01

Study 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.

02

Conditions studied

  • Multi-resistant Enterobacteriaceae Colonisation
  • Pregnancy
  • Nosocomial Outbreaks
03

In context

Lead sponsor

Corporacion Parc Tauli is the lead sponsor of 163 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Screening done after 48 hours of admission
  • When delivery occurs before screening is performed
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
580 participants (estimated)
Patient registry
No

Groups and cohorts

  • Pregnant women colonized by resistant enterobacteria
06

What researchers measure

Primary outcomes

  1. Prevalence of multi-resistant enterobacteriaceae colonisation in less than 32 weeks pregnant women

    Time frame: 18 months

Secondary outcomes

  1. Prevalence of multi-resistant enterobacteriaceae colonisation of African or Asian pregnant women

    Time frame: 18 months

  2. Incidence of multi-resistant enterobacteriaceae colonisation of pregnant women admitted to the hospital by preterm premature rupture of membranes (PPROM)

    Time frame: 18 months

  3. Transmission rate from the colonized woman to the newborn

    Time frame: 18 months

  4. Number of multi-resisitant enterobacteriacea sepsis in the Neonatal Unit

    Time frame: 18 months

07

Study locations

1 of 1 sites recruiting
  • Hospital de Sabadell. Corporacio Sanitaria Parc Tauli
    Sabadell, Barcelona 08208, Spain
    • Victoria Aldecoa · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02631226
Lead sponsor
Corporacion Parc Tauli
Responsible party
Victoria Aldecoa-Bilbao (Principal Investigator, Corporacion Parc Tauli) — Principal investigator
First posted
Dec 16, 2015
Start date
Feb 2016
Primary completion
Jul 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Feb 11, 2016

Study contacts

Victoria Aldecoa-Bilbao, M.D.
Contact
valdecoa@tauli.cat
0034937231010 ext. 29314

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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