Outcomes of Obstetric Patients With COVID-19 Disease in the ICU

Completed

• Conditions: COVID-19; Intensive Care Unit; Morality; Obstetric Anesthesia Problems

• Registration Number: NCT05264987
• Lead Sponsor: Turkiye Yuksek Ihtisas Education and Research Hospital

Brief Summary

Although several studies are conducted in the general population researching the clinical and laboratory parameters predicting the progression to severe disease in COVID-19, the data are very few in obstetric patients. Therefore,the investigators aimed to evaluate the characteristics, prognosis, laboratory parameters, and mortality of obstetric patients followed up in the intensive care unit (ICU) due to severe COVID-19 disease and to determine the factors affecting mortality.

Detailed Description

This study was a single-center, retrospective, and observational trial and carried out with the principles of the Declaration of Helsinki. All patient demographics and information were analyzed retrospectively from the patient files.

Demographic data, obstetric histories, comorbidities, treatments received in the intensive care unit (ICU), delivery types, anesthesia types, and outcomes of newborns and mothers were retrospectively evaluated from the medical records. The need for the mechanical ventilator, the length of stay in the ICU, and outcomes of mothers were recorded. Laboratory findings were noted on the first day of admission to the ICU, including routine complete blood count, liver and kidney function, coagulation parameters, C-reactive protein (CRP), and albumin levels. Then neutrophil to lymphocyte (N/L) ratio, platelet to lymphocyte (P/L) ratio, and CRP to albumin (CRP/Alb) ratio were calculated. Deceased patients were evaluated in detail.

Study Timeline

• Study Start: 2020-03-11
• Primary Completion: 2021-09-15
• Study Completion: 2021-12-28
• Study First Submitted: 2022-02-24
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-02
• Last Update Submitted: 2022-03-02
• Study First Posted: 2022-03-03
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

Inclusion Criteria

• Obstetric patients (during the pregnancy and postpartum period, from the beginning of pregnancy and up to 42 days after delivery) hospitalized in the intensive care unit of our tertiary care hospital
• Patients who had positive PCR nasopharyngeal swabs for COVID-19

Exclusion Criteria

• Patients who had negative PCR nasopharyngeal swabs for COVID-19 and were clinically suspicious

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
intensive care follow-up	up to 200 days	mortality

Trial Locations

Locations (1)

Derya Karasu; 🇹🇷 Bursa, Yıldırım, Turkey