- ICH GCP
- US Clinical Trials Registry
- 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.
July 1, 2023 updated by: Nur Baykara, Turkish Intensive Care Society
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
597
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kocaeli, Turkey, 41001
- Kocaeli University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maternal Mortality in ICU
Time Frame: Prognosis of pregnant/puerperal women with COVID-19 admitted to ICU
|
Prognosis of pregnant/puerperal women with COVID-19 admitted to ICU
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2022
Primary Completion (Actual)
July 30, 2022
Study Completion (Actual)
July 30, 2022
Study Registration Dates
First Submitted
June 26, 2023
First Submitted That Met QC Criteria
July 1, 2023
First Posted (Actual)
July 5, 2023
Study Record Updates
Last Update Posted (Actual)
July 5, 2023
Last Update Submitted That Met QC Criteria
July 1, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KÜ GOKAEK-2021/23.27
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Key Words:COVID-19; Pregnancy; Intensive Care Unit; SARS-CoV-2; Mortality
-
Hospices Civils de LyonBioMérieuxRecruiting
-
Sisli Hamidiye Etfal Training and Research HospitalCompletedMortality | Intensive Care UnitTurkey
-
University Hospital, Clermont-FerrandUnknownDelirium | SARS-CoV-2 Infection | Encephalopathy | Intensive Care Unit Patient | Neurological AbnormalityFrance
-
University of Colorado, DenverColumbia University; Brigham and Women's Hospital; University of Washington; Tulane... and other collaboratorsCompletedDepression | SARS-CoV 2 | Respiratory Failure | Anxiety | Post Traumatic Stress Disorder | Corona Virus Infection | Family Members | Post Intensive Care Unit SyndromeUnited States
-
AGIR à DomLaboratoire TIMC-IMAG; DrinkHRW, British Columbia, CanadaActive, not recruitingCovid19 | SARS-CoV-2 | AMBULATORY CAREFrance, Morocco, Serbia
-
Davita Clinical ResearchCompletedSARS-CoV-2 Infection (Asymptomatic) | SARS-CoV-2 Infection (Symptomatic)United States
-
Universidade de Cabo VerdeUniversity of Southern Denmark; European and Developing Countries Clinical... and other collaboratorsCompletedCOVID-19 | SARS-CoV-2 | BCG | Health Care WorkerCape Verde
-
Centre Hospitalier Annecy GenevoisCompletedCovid19 | Health Care WorkerFrance
-
Nantes University HospitalNational Research Agency, FranceCompletedCovid19 | Respiratory Distress Syndrome | SARS-CoV-2 | Intensive Care Units | PathologyFrance
-
Meir Medical CenterRecruiting