Organ Dysfunction Score for Obstetric Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorDaniela Vasquez

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients <18 years old

Non-pregnant patients

≥ 4 days postpartum

Patients or surrogates not giving consent to participate

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

    Other intervention

    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.

Treatment groups

130 Participants
are divided into 1 treatment group
Group A: Obstetric patients= pregnant and postpartum (< 3 days) patients requiring ICU admission1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
From patient enrollment to patient discharge from ICU (alive/dead) or 28-days post-enrollment, whichever occur first.
2

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

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Daniela Vasquez

Lead sponsor

Argentinian Intensive Care Society

Sponsor institution