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

COVID-19 Clinical Trial

Official title:

Evaluation of Outcomes of Obstetric Patients With COVID-19 Disease Followed up in the Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05264987
• Other study ID #: 2011-KAEK-25 2021/06-20
• Status: Completed
• Start date: March 11, 2020
• Est. completion date: December 28, 2021

Study information

• Verified date: March 2022
• Source: Turkiye Yuksek Ihtisas Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 28, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Intensive Care Unit
• Morality
• Obstetric Anesthesia Problems

Intervention

Other:
• intensive care follow-up
The need for the mechanical ventilator, the length of stay in the intensive care unit, and outcomes of mothers were recorded. Deceased patients were evaluated in detail.

Locations

Country	Name	City	State
Turkey	Derya Karasu	Bursa	Yildirim

Sponsors (1)

Lead Sponsor	Collaborator
Turkiye Yuksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intensive care follow-up	mortality	up to 200 days