Organ Dysfunction Score for Obstetric Patients

NCT07068022 | Recruiting

• 1 other identifier: PRIISABA 15646
• Study Type: observational
• Target: 130
• Locations: 4 countries
• Sites: 18

Brief 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.

Conditions

Pregnancy; Postpartum; Organ Dysfunction; Critical Care, Intensive Care; Sepsis

Keywords

Sequential Organ Failure Assessment score; Pregnancy; Postpartum; Critical care; Intensive Care Unit; Creatinine; Peripheral oxygen saturation; Hypotension; Maternal mortality; Mortality; Sepsis; Septic shock; Multicenter study

Outcome Measures

Primary Outcomes (2)

• Obstetric patients ICU mortality

  Non-surviving obstetric patients admitted to ICU during the study period/ all obstetric patients admitted to ICU during the same period

  From patient enrollment to patient discharge from ICU (alive/dead) or 28-days post-enrollment, whichever occur first.

• Sepsis-related obstetric ICU mortality

  Non-surviving obstetric patients admitted to ICU during the study period, presenting sepsis on admission or developing sepsis during their ICU-LOS/All obstetric patients admitted to ICU during the same period, presenting sepsis on admission or developing sepsis during their ICU-LOS

  From patient enrollment to patient discharge from ICU (alive/dead) or 28-days post-enrollment, whichever occur first.

Study Arms (1)

Obstetric patients= pregnant and postpartum (< 3 days) patients requiring ICU admission

All pregnant and postpartum (\< 3 days) patients requiring ICU admission will be followed during their ICU-LOS. The predictive validity for ICU mortality of an adjusted to obstetric patients Sequential Organ Failure Assessment (SOFA-OBS) score will be compared to the predictive validity of a non-modified Sequential Organ Failure Assessment (SOFA) score.

Other: Organ dysfunction score adjusted to obstetric patients (SOFA-OBS)

Interventions

Organ dysfunction score adjusted to obstetric patients (SOFA-OBS) OTHER

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.

Obstetric patients= pregnant and postpartum (< 3 days) patients requiring ICU admission

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited in ICUs from third level hospitals from Latin American countries.

You may qualify if:

• All of the following=
• Pregnant (at any gestational age) or post-partum patients (at ≤3 days postpartum)
• ≥ 18 years old
• Requiring admission to ICU for any reason
• Staying in the ICU for ≥ 24h
• Giving her consent to participate. Patients will be recruited consecutively until reaching the sample size.

You may not qualify if:

• Any of the following=
• Patients \<18 years old
• Non-pregnant patients
• ≥ 4 days postpartum
• Patients or surrogates not giving consent to participate
• ICU-LOS \< 24 h

Sponsors & Collaborators

• Daniela Vasquez: lead

Study Sites (18)

Sanatorio Itoiz

Avellaneda, Buenos Aires, Argentina

RECRUITING

Hospital Cuenca Alta Néstor Kirchner

Canuelas, Buenos Aires, Argentina

RECRUITING

Sanatorio Anchorena Recoleta

City of Buenos Aires, Buenos Aires, 1894, Argentina

RECRUITING

Hospital Simplemente Evita

González Catán, Buenos Aires, Argentina

RECRUITING

Hospital Mi Pueblo Florencio Varela

San Juan Bautista, Buenos Aires, Argentina

RECRUITING

Hospital Thompson

San Martín, Buenos Aires, Argentina

RECRUITING

Sanatorio Anchorena San Martín

San Martín, Buenos Aires, Argentina

RECRUITING

Hospital Materno Infantil Dr. F Escardó

Tigre, Buenos Aires, Argentina

RECRUITING

Hospital de la Madre y el Niño

La Rioja, La Rioja Province, Argentina

RECRUITING

Hospital Regional Diego Paroissien

Mendoza, Mendoza Province, Argentina

NOT YET RECRUITING

Maternidad Provincial Teresita Baigorria

San Luis, San Luis Province, Argentina

NOT YET RECRUITING

Hospital Regional Ramón Carrillo

Santiago del Estero, Santiago del Estero Province, Argentina

NOT YET RECRUITING

Sanatorio Antártida

City of Buenos Aires, Argentina

NOT YET RECRUITING

Sanatorio Finochietto

City of Buenos Aires, Argentina

NOT YET RECRUITING

Sanatorio Guemes

City of Buenos Aires, Argentina

RECRUITING

Hospital Gineco Obstétrico Isidro Ayora

Quito, Ecuador

RECRUITING

Hospital Materno Infantil 1 de mayo

San Salvador, El Salvador

NOT YET RECRUITING

Hospital de Clínicas Dr. Manuel Quintela

Montevideo, Uruguay

NOT YET RECRUITING

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MeSH Terms

Conditions

Sepsis; Hypotension; Maternal Death; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Parental Death; Death; Shock

Study Officials

• Daniela N. Vasquez, MD

  Sanatorio Anchorena Recoleta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniela N. Vasquez, MD

CONTACT

+5492215041762; danielavasquez73@gmail.com

Andrea V. Das Neves, MD

CONTACT

+5492215792555; av.dasneves@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor, Researcher

Study Record Dates

• First Submitted: June 28, 2025
• First Posted: July 16, 2025
• Study Start: October 6, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: April 28, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

AR (15); EC (1); EL (1); UR (1)