Validation of the Quick Sequential [Sepsis-related] Organ Failure Assessment (qSOFA) in Obstetric Patients
Validation of the Quick Sequential [Sepsis-related] Organ Failure Assessment (qSOFA) in Obstetric Patients
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.
Inclusion Criteria:

 -  Patients in a state of pregnancy with a single fetus between 14 and 49 years old.

 -  Pregnant women (any gestational age) defined as a positive gravindex test and an
 obstetric ultrasound to prove it.

 -  Any suspected or confirmed infection during current hospital stay (primary admission
 or readmission) with or without organ dysfunction

 -  Any clinical signs suggestive of infection (eg, fever)

 -  Request for culture of body fluids (blood, urine, cerebrospinal fluid, etc.) or swab
 specimen (nasopharyngeal, oropharyngeal);

 -  Non-prophylactic use of antibiotics or other antimicrobials during admission or during
 hospital stay.

 -  Any health care related infection (eg, surgical site, episiotomy, IV, venipuncture,
 urinary catheterization, central line, etc.)

 -  Urinary tract infection of the lower urinary tract that requires hospitalization and
 in-hospital management for more than 48 hours.

 -  Herpes simplex, herpes zoster (shingles) with associated liver failure.

 Note: observations on the inclusion criteria:

 -  Eligible women who remain in the health center for 12 hours or more, regardless of
 formal administrative admission, will be included in the study.

 -  Eligible women admitted or readmitted to a participating health center, regardless of
 length of hospital stay, will be included in the study.

 Exclusion Criteria:

 -  Pregnant women of any age who do not sign the informed consent.

 -  Pregnant minors who do not sign the consent.

 -  Any non-serious or localized infection

 -  Vaginosis, candidiasis

 -  Fungal skin infections (athlete's foot, ringworm)

 -  Otitis o Pharyngitis

 -  Any chronic uncomplicated infection

 -  Sexually transmitted infections (gonorrhea, syphilis, Trichomonas, chlamydia,
 hepatitis, HIV).

 -  Tuberculosis.

 -  Any colonization Microorganisms without clinical signs / symptoms)

 -  Known vaginal, urethral and / or rectal colonization of group B beta-hemolytic
 streptococcus.

 -  Asymptomatic bacteriuria

 -  Known oropharyngeal colonization

 -  Patients with surgical wound infection other than caesarean section (hysterectomy,
 laparotomy or others)

 -  Any iatrogenic / hyperthermic hypothermia (eg related to epidural, thyroid storm,
 prostaglandin administration) during hospital stay.

 -  Use of any prescription of prophylactic antibiotics (eg, for colonization of
 beta-hemolytic streptococcus group B, after cesarean section, manual removal of the
 placenta, vaginal delivery);

 -  Patients referred from other institutions with more than 24 hours of management