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Organ dysfunction score for pregnant and early postpartum patients

Development and Validation of an Obstetric Organ Dysfunction Score to Predict Mortality in Intensive Care Unit: A Multicenter, Prospective, Cohort Study

Observational Argentinian Intensive Care Society · NCT07068022

This project will test a pregnancy‑adjusted SOFA score (SOFA-OBS) and whether pulse oximeter oxygenation can replace arterial measures to predict mortality in pregnant or up to 3-day postpartum adults admitted to the ICU.

Quick facts

Study typeObservational
Enrollment130 (estimated)
Ages18 Years and up
SexFemale
SponsorArgentinian Intensive Care Society Academic / other
Locations18 sites (Avellaneda, Buenos Aires and 17 other locations)
Trial IDNCT07068022 on ClinicalTrials.gov

What this trial studies

This is an observational cohort of adult pregnant or ≤3-day postpartum patients admitted to the ICU, aiming to enroll about 130 participants. Investigators will collect routine clinical data and laboratory results already obtained by ICU teams and will not perform additional interventions. They will develop a modified SOFA score (SOFA-OBS) calibrated for obstetric physiology and compare its ability to predict ICU mortality against the standard SOFA. The study will also compare non-invasive pulse oximeter-based oxygenation measures with arterial oxygenation measures to see if the non-invasive approach performs similarly.

Who should consider this trial

Good fit: Adults (≥18 years) who are pregnant at any gestational age or ≤3 days postpartum, require ICU admission for ≥24 hours, and consent to participate are the intended candidates.

Not a fit: Non-pregnant patients, those >3 days postpartum, patients with ICU length of stay under 24 hours, pediatric patients, or those in whom pulse oximetry is unreliable are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, a validated pregnancy-adjusted organ dysfunction score and reliable pulse oximetry approach could help clinicians recognize high-risk obstetric ICU patients earlier and reduce the need for arterial blood gases.

How similar studies have performed: The standard SOFA score is well validated for mortality prediction in general adult ICU populations, but adapting and validating it specifically for pregnant and early postpartum patients is relatively novel with limited prior validation.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

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.

Exclusion Criteria:

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

Where this trial is running

Avellaneda, Buenos Aires and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions PregnancyPostpartumOrgan DysfunctionCritical Care, Intensive CareSepsisSequential Organ Failure Assessment scoreCritical careIntensive Care Unit
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.