Organ dysfunction score for pregnant and early postpartum patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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, 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

Study contacts

• Principal investigator: Daniela N. Vasquez, MD — Sanatorio Anchorena Recoleta
• Study coordinator: Daniela N. Vasquez, MD
• Email: danielavasquez73@gmail.com
• Phone: +5492215041762

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.