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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infected without an SMO | Defined as an acute infection not associated with admission to the intensive care unit (ICU), mechanical ventilation, or the use of vasopressors. | ||
| Infected with an SMO | defined as an acute infection associated with intensive care unit (ICU) admission, mechanical ventilation, or vasopressor use. |
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| Measure | Description | Time Frame |
|---|---|---|
| Admission to intensive care unit | need or admission to an intensive care unit | 28 days |
| Use of vasopressors | use of vasoactive drugs (norepinephrine, epinephrine, vasopressin) | 28 days |
| Prolonged ICU stay | Stay in intensive care unit for 72 hours | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Additional interventions | need for surgery (cesarean section - emergency hysterectomy, hysterectomy, chest tubes, etc.), invasive mechanical ventilation, use of arterial line, among others. | 28 days |
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Inclusion Criteria:
Note: observations on the inclusion criteria:
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
Any chronic uncomplicated infection
Any colonization Microorganisms without clinical signs / symptoms)
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
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Carmelo R Dueñas-Castell, Msc | Gestion Salud IPS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gestion Salud | Cartagena | Departamento de BolÃvar | 130015 | Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25103301 | Background | Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5. | |
| 22907333 | Background | Surgers L, Valin N, Carbonne B, Bingen E, Lalande V, Pacanowski J, Meyohas MC, Girard PM, Meynard JL. Evolving microbiological epidemiology and high fetal mortality in 135 cases of bacteremia during pregnancy and postpartum. Eur J Clin Microbiol Infect Dis. 2013 Jan;32(1):107-13. doi: 10.1007/s10096-012-1724-5. Epub 2012 Aug 21. |
| Label | URL |
|---|---|
| Maternal mortality - WHO | View source |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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| 22251396 | Background | Acosta CD, Bhattacharya S, Tuffnell D, Kurinczuk JJ, Knight M. Maternal sepsis: a Scottish population-based case-control study. BJOG. 2012 Mar;119(4):474-83. doi: 10.1111/j.1471-0528.2011.03239.x. Epub 2012 Jan 18. |
| 12848644 | Background | Kankuri E, Kurki T, Carlson P, Hiilesmaa V. Incidence, treatment and outcome of peripartum sepsis. Acta Obstet Gynecol Scand. 2003 Aug;82(8):730-5. doi: 10.1034/j.1600-0412.2003.00265.x. |
| 1303622 | Background | Bone RC, Balk RA, Cerra FB, Dellinger RP, Fein AM, Knaus WA, Schein RM, Sibbald WJ. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. The ACCP/SCCM Consensus Conference Committee. American College of Chest Physicians/Society of Critical Care Medicine. Chest. 1992 Jun;101(6):1644-55. doi: 10.1378/chest.101.6.1644. |
| 26903338 | Background | Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287. |
| 26792141 | Background | Jain S, Guleria K, Suneja A, Vaid NB, Ahuja S. Use of the Sequential Organ Failure Assessment score for evaluating outcome among obstetric patients admitted to the intensive care unit. Int J Gynaecol Obstet. 2016 Mar;132(3):332-6. doi: 10.1016/j.ijgo.2015.08.005. Epub 2015 Dec 2. |
| 16148470 | Background | Arts DG, de Keizer NF, Vroom MB, de Jonge E. Reliability and accuracy of Sequential Organ Failure Assessment (SOFA) scoring. Crit Care Med. 2005 Sep;33(9):1988-93. doi: 10.1097/01.ccm.0000178178.02574.ab. |
| Weekly Epidemiological Bulletin, number 21 of 2017 (May 21 - May 27) | View source |