Clinical trial NCT05930340: Clinical Characteristics, Outcomes and Risk Factors for Mortality in Pregnant/Puerperal Women With COVID-19 Admitted to ICU in Turkey: a Multicenter, Retrospective Study From a Middle-income Country.
Official title: Clinical Characteristics, Outcomes and Risk Factors for Mortality in Pregnant/Puerperal Women With COVID-19 Admitted to ICU in Turkey: a Multicenter, Retrospective Study From a Middle-income Country.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Key Words:COVID-19; Pregnancy; Intensive Care Unit; SARS-CoV-2; Mortality
Lead sponsor: Turkish Intensive Care Society
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 597
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All SARS-CoV-2-infected pregnant or puerperal women (up to 6 weeks after birth) who were admitted to participating ICUs between 1 March 2020 and 1 January 2022.

Brief summary: We performed a national, multicenter, retrospective, cohort study. The study was announced on the Turkish Society of Intensive Care Medicine website, which included the study protocol, and the directors of ICUs caring for COVID-19 patients were invited. The study population comprised all SARS-CoV-2-infected pregnant or puerperal women (up to 6 weeks after birth) who were admitted to participating ICUs between 1 March 2020 and 1 January 2022. The exclusion criteria were patients aged \<18 years old, patients with negative COVID-19 PCR test results, patients with active malignant disease, and organ transplant recipients.The following data were collected: patient demographics, gestational age or postpartum day on admission, date of ICU admission, comorbidities, vaccination status, Acute Physiology and Chronic Health Evaluation II (APACHE-2) and Sequential Organ Failure Assessment (SOFA) scores on admission, the worst SOFA score during the ICU stay, the ratio of lung infiltrates if diagnostic imaging was performed, the time interval from the start of symptoms to ICU admission, the duration of ICU stay, laboratory values on admission and the worst laboratory values during the ICU stay, the development of extrapulmonary organ injury,the presence of non-COVID-19 infections, The worst PaO2/FiO2 ratio during the ICU stay, the most invasive respiratory support method applied, and therapies were also recorded. Immunomodulatory therapies such as corticosteroids, IL inhibitors, intravenous immunoglobulin (IVIG) and cytokine hemadsorption, were also recorded. Fetal and neonatal complications were collected. LASSO regression and multiple logistic regression analyses were used to identify risk factors for maternal ICU mortality.


Eligibility criteria: Inclusion Criteria:

* The study population comprised all SARS-CoV-2-infected pregnant or puerperal women (up to 6 weeks after birth) who were admitted to participating ICUs between 1 March 2020 and 1 January 2022.

Exclusion Criteria:

* Patients aged \<18 years old, patients with negative COVID-19 PCR test results, patients with active malignant disease, and organ transplant recipients.

Primary outcomes:
measure: Maternal Mortality in ICU
timeFrame: Prognosis of pregnant/puerperal women with COVID-19 admitted to ICU
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University
Study officials:
References: