An observational study in Severe Infection, sponsored by Fundación Grupo de Investigación en Cuidados Intensivos y Obstetricia. Completed at 1 site in Colombia. Open to female participants aged 14 Years to 49 Years. Per ClinicalTrials.gov, last updated 2020-11-09.
Sponsored by Fundación Grupo de Investigación en Cuidados Intensivos y Obstetricia · Observational
Research problem: In 1991, the terms Systemic Inflammatory Response Syndrome (SIRS), severe sepsis, and septic shock were introduced, based on the pro-inflammatory theory, conforming to a list of classification criteria for each one. New criteria were recently created in search of coherence with the pathophysiological process that generates the infection in the host: SOFA and qSOFA scores. Neither of these two criteria has been standardized in the obstetric patient, taking into account the physiological alteration of many of the clinical and laboratory parameters that occur in pregnancy. The question that arises then is: Are the new sepsis criteria qSOFA and SOFA valid in comparison with the previous SIRS criteria for predicting adverse maternal and neonatal outcomes in obstetric patients diagnosed with infection? Aim: To evaluate the predictive model quick Sequential [Sepsis-related] Organ Failure Assessment (qSOFA) in comparison with the SIRS criteria for the prognosis of severe infection-sepsis in obstetric patients and adverse neonatal outcomes in different cities of Colombia.
Methodology: a longitudinal prospective cohort multicenter study will be carried out in selected centers in Colombia, with a data collection duration of at least 12 months. Data will be collected on clinical characteristics, health outcomes, and medical practices. Study participants will be followed during their stay at the health center. Follow-up will end at hospital discharge, transfer to a facility outside of participating geographic areas, or death. Neonates born to mothers included in the study will be followed until discharge from the hospital or 7 days after birth if they are still in the hospital, whichever comes first.
Expected results: This study seeks to evaluate the predictive model q SOFA and the prognosis of sepsis in obstetrics in comparison with the SIRS criteria, hoping to find that qSOFA is superior to the SIRS criteria for the identification of which obstetric patients diagnosed with an infection they will progress to sepsis and which patients with sepsis progress to septic shock, this would translate both at the maternal and neonatal level in a reduction of adverse events, prolonged stays, disabilities, sequelae, in addition to allowing preventive actions and control, which finally translate into protocols that allow better management of this entity.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 2,125 is above the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →Fundación Grupo de Investigación en Cuidados Intensivos y Obstetricia is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant women, childbirth or within 42 days of termination of pregnancy, with infectious symptoms of any kind (obstetric - non-obstetric) who attend and are hospitalized in the selected clinics during the study period.
Note: observations on the inclusion criteria:
Exclusion Criteria:
Any non-serious or localized infection
Any chronic uncomplicated infection
Any colonization Microorganisms without clinical signs / symptoms)
Defined as an acute infection not associated with admission to the intensive care unit (ICU), mechanical ventilation, or the use of vasopressors.
defined as an acute infection associated with intensive care unit (ICU) admission, mechanical ventilation, or vasopressor use.
Admission to intensive care unit
need or admission to an intensive care unit
Time frame: 28 days
Use of vasopressors
use of vasoactive drugs (norepinephrine, epinephrine, vasopressin)
Time frame: 28 days
Prolonged ICU stay
Stay in intensive care unit for 72 hours
Time frame: 28 days
Additional interventions
need for surgery (cesarean section - emergency hysterectomy, hysterectomy, chest tubes, etc.), invasive mechanical ventilation, use of arterial line, among others.
Time frame: 28 days
Plan to share: Undecided
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Fundación Grupo de Investigación en Cuidados Intensivos y Obstetricia