Organ Dysfunction Score for Obstetric Patients
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
| Condition(s) | Pregnancy, Postpartum, Organ Dysfunction, Critical Care, Intensive Care, Sepsis |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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 ar |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | Daniela Vasquez |
| Locations | Avellaneda, Buenos Aires, Argentina; Canuelas, Buenos Aires, Argentina; City of Buenos Aires, Buenos Aires, Argentina; González Catán, Buenos Aires, Argentina; San Juan Bautista, Buenos Aires, Argentina; San Martín, Buenos Aires, Argentina (+12 more sites) |
| Start date | 2025-10-06 |
| NCT ID | NCT07068022 |
| Official listing | https://clinicaltrials.gov/study/NCT07068022 |