Actively Recruiting
Organ Dysfunction Score for Obstetric Patients
Led by Daniela Vasquez · Updated on 2026-04-28
130
Participants Needed
18
Research Sites
72 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Organ Dysfunction Score for Obstetric Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant at any gestational age or within 3 days postpartum
- 18 years old or older
- Requires admission to intensive care unit (ICU) for any reason
- Expected ICU stay of at least 24 hours
- Provides consent to participate in the study
You will not qualify if you...
- Younger than 18 years old
- Not pregnant or beyond 3 days postpartum
- Does not provide consent to participate
- ICU stay less than 24 hours
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 18 locations
1
Sanatorio Itoiz
Avellaneda, Buenos Aires, Argentina
Actively Recruiting
2
Hospital Cuenca Alta Néstor Kirchner
Canuelas, Buenos Aires, Argentina
Actively Recruiting
3
Sanatorio Anchorena Recoleta
City of Buenos Aires, Buenos Aires, Argentina, 1894
Actively Recruiting
4
Hospital Simplemente Evita
González Catán, Buenos Aires, Argentina
Actively Recruiting
5
Hospital Mi Pueblo Florencio Varela
San Juan Bautista, Buenos Aires, Argentina
Actively Recruiting
6
Hospital Thompson
San Martín, Buenos Aires, Argentina
Actively Recruiting
7
Sanatorio Anchorena San Martín
San Martín, Buenos Aires, Argentina
Actively Recruiting
8
Hospital Materno Infantil Dr. F Escardó
Tigre, Buenos Aires, Argentina
Actively Recruiting
9
Hospital de la Madre y el Niño
La Rioja, La Rioja Province, Argentina
Actively Recruiting
10
Hospital Regional Diego Paroissien
Mendoza, Mendoza Province, Argentina
Not Yet Recruiting
11
Maternidad Provincial Teresita Baigorria
San Luis, San Luis Province, Argentina
Not Yet Recruiting
12
Hospital Regional Ramón Carrillo
Santiago del Estero, Santiago del Estero Province, Argentina
Not Yet Recruiting
13
Sanatorio Antártida
City of Buenos Aires, Argentina
Not Yet Recruiting
14
Sanatorio Finochietto
City of Buenos Aires, Argentina
Not Yet Recruiting
15
Sanatorio Guemes
City of Buenos Aires, Argentina
Actively Recruiting
16
Hospital Gineco Obstétrico Isidro Ayora
Quito, Ecuador
Actively Recruiting
17
Hospital Materno Infantil 1 de mayo
San Salvador, El Salvador
Not Yet Recruiting
18
Hospital de Clínicas Dr. Manuel Quintela
Montevideo, Uruguay
Not Yet Recruiting
Research Team
D
Daniela N. Vasquez, MD
CONTACT
A
Andrea V. Das Neves, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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