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Organ Dysfunction Score for Obstetric Patients
Sponsor: Daniela Vasquez
Summary
The goal of this observational study is to develop and evaluate an organ dysfunction score adapted to pregnancy and early puerperium (SOFA-OBS) that also incorporates a non-invasive tool to evaluate respiratory function (pulse oximeter). The main question it aims to answer is: Does an organ dysfunction score adapted to pregnant and postpartum patients have a higher capacity to predict mortality than a non-adjusted organ dysfunction score? Participants: Patients requiring ICU (Intensive Care Units) admission, who are either pregnant or postpartum (up to 3 days after giving birth). The investigators aimed to include 130 participants. The investigators will only collect participants' data and laboratory results that ICU doctor usually need for clinical practice. No additional interventions are required. Moreover, the investigators will evaluate if measuring participants' oxygenation through a non-invasive tool (pulse oximeter) is equally effective as measuring oxygenation by an arterial puncture. Background: When managing severely ill patients in ICU, the investigators often use what it is called scores. Scores refer to a numerical value assigned to a patient's condition, which often predict outcome. The Sequential Organ Failure Assessment (SOFA) score is a scoring system that assess severity of organ dysfunction (in liver, kidney, blood pressure, respiratory, neurologic and platelets). It also identifies patients with severe infections (sepsis) and patients with bad outcomes. Patients undergoing pregnancy or early postpartum develop physiological changes, such us a decrease in creatinine (a laboratory test measuring kidney function) and a decrease in blood pressure during the second trimester. These changes are not considered by the SOFA score. Actually, there is not an organ dysfunction score adapted to pregnant/postpartum patients to be used in the ICU. Moreover, a blood sample taken by arterial puncture is required to evaluate respiratory function by the SOFA score, which is a painful procedure. Instead, the investigators could evaluate respiratory function using a pulse oximeter, which measures peripheral oxygen saturation without needing an arterial puncture. Potential benefits: A SOFA-OBS would hopefully become a more precise tool than general SOFA to evaluate organ dysfunction and to predict outcome among these patients. It would also help to detect sepsis earlier and treat it promptly, which might help reducing its mortality.
Official title: Development and Validation of an Obstetric Organ Dysfunction Score to Predict Mortality in Intensive Care Unit: A Multicenter, Prospective, Cohort Study
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
130
Start Date
2025-08-01
Completion Date
2027-02-28
Last Updated
2025-07-16
Healthy Volunteers
No
Interventions
Organ dysfunction score adjusted to obstetric patients (SOFA-OBS)
The obstetric SOFA (SOFA-OBS) adjusts renal and cardiovascular variables to physiological changes of pregnancy. Moreover, it simplifies respiratory evaluation, in terms of replacing arterial blood gases (ABG) for peripheral oxygen saturation/fraction of inspired oxygen (spO2/FiO2), when ABGs were not available. Variables unchanged during pregnancy (neurologic, hepatic and platelets), won't be modified.
Locations (17)
Sanatorio Itoiz
Avellaneda, Buenos Aires, Argentina
Sanatorio Anchorena Recoleta
City of Buenos Aires, Buenos Aires, Argentina
Hospital Simplemente Evita
González Catán, Buenos Aires, Argentina
Hospital Mi Pueblo Florencio Varela
San Juan Bautista, Buenos Aires, Argentina
Hospital Thompson
San Martín, Buenos Aires, Argentina
Sanatorio Anchorena San Martín
San Martín, Buenos Aires, Argentina
Hospital Materno Infantil Dr. F Escardó
Tigre, Buenos Aires, Argentina
Hospital de la Madre y el Niño
La Rioja, La Rioja Province, Argentina
Hospital Regional Diego Paroissien
Mendoza, Mendoza Province, Argentina
Maternidad Provincial Teresita Baigorria
San Luis, San Luis Province, Argentina
Hospital Regional Ramón Carrillo
Santiago del Estero, Santiago del Estero Province, Argentina
Sanatorio Antártida
City of Buenos Aires, Argentina
Sanatorio Finochietto
City of Buenos Aires, Argentina
Sanatorio Guemes
City of Buenos Aires, Argentina
Hospital Gineco Obstétrico Isidro Ayora
Quito, Ecuador
Hospital Materno Infantil 1 de mayo
San Salvador, El Salvador
Hospital de Clínicas Dr. Manuel Quintela
Montevideo, Uruguay