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NOT YET RECRUITING
NCT07068022

Organ Dysfunction Score for Obstetric Patients

Sponsor: Daniela Vasquez

View on ClinicalTrials.gov

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

OTHER

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