Actively Recruiting

Age: 18Years +
FEMALE
NCT07068022

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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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

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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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