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.

NCT ID: NCT05930340

Last Updated: 2023-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

597 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-15

Study Completion Date

2022-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Key Words:COVID-19; Pregnancy; Intensive Care Unit; SARS-CoV-2; Mortality

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Turkish Intensive Care Society

OTHER

Sponsor Role lead

Responsible Party

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Nur Baykara

Prof.Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kocaeli University

Kocaeli, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KÜ GOKAEK-2021/23.27

Identifier Type: -

Identifier Source: org_study_id

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