NCT07068022: SOFA-OBS

Organ Dysfunction Score for Obstetric Patients

Not yet recruiting Last updated 16 July 2025

What this trial tests

trial testing Organ dysfunction score adjusted to obstetric patients (SOFA-OBS) in Pregnancy in 130 participants. Not yet recruiting.

Timeline

1 August 2025

Primary endpoint
1 December 2026

28 February 2027

Quick facts

Lead sponsor	Daniela Vasquez
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	130
Start date	1 August 2025
Primary completion	1 December 2026
Estimated completion	28 February 2027
Sites	17 locations across El Salvador, Argentina, Ecuador, Uruguay

Drugs / interventions tested

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

Conditions studied

• Pregnancy — all drugs for Pregnancy →
• Postpartum — all drugs for Postpartum →
• Organ Dysfunction — all drugs for Organ Dysfunction →
• Critical Care, Intensive Care — all drugs for Critical Care, Intensive Care →

Sponsor

Daniela Vasquez

Who can join

18 and older, female only, with Pregnancy or Postpartum. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.