Epidemiological Investigation of Sepsis in Obstetrics Admitted to ICU

Intensive Care Units Clinical Trial

Official title:

Epidemiological Investigation of Sepsis in Obstetrics Admitted to ICU From 2008 to 2016 in Beijing China: A First Multicenter Report

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05055388
• Other study ID #: LM2020443
• Status: Enrolling by invitation
• Start date: December 3, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: September 2021
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Sepsis is still the main cause of maternal death, accounting for 11% of maternal deaths. Early identification of high risk factors of sepsis and early intervention can improve the prognosis of pregnant women with sepsis. At present, there is no epidemiological investigation report on sepsis in ICU in China.

Description:

Although great progress has been made in maternal care in China in recent years, the maternal mortality rate in China has remained high in the past three years, fluctuating from 19.6-20.1/100000, and there is still a large gap between China and developed countries (12.1/100000). Sepsis is still the main cause of maternal death, accounting for 11% of maternal deaths; Early identification of high risk factors of sepsis and early intervention can improve the prognosis of pregnant women with sepsis. At present, there is no epidemiological investigation report on sepsis in ICU in China. A total of 160 cases of maternal sepsis with ICU admission in any trimester of pregnancy or within 42 days of delivery were reviewed between January 1, 2008, and December 31, 2019. The demographic data including age and gestational age, mode of delivery, the maximal SOFA score, invasive operation before sepsis, sepsis focuses, intervention, microbial culture results, body temperature and blood routine were reviewed to investigate the incidence and mortality of maternal sepsis in intensive care unit, as well as the incidence of multidrug-resistant bacteria and the risk factors of multidrug resistance.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 160
• Est. completion date: May 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria: Obstetrics with sepsis in any trimester of pregnancy or within 42 days of delivery -

Exclusion Criteria: The electronic medical record is lost. Patients with incomplete infection data: if the temperature sheet is ambiguous and the temperature data is not recorded in the medical record.

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Related Conditions & MeSH terms

• Drug Resistance, Multiple
• Intensive Care Units
• Pregnancy Complications, Infectious
• Sepsis
• Toxemia

Intervention

Other:
• Multidrug-resistant bacteria
Multidrug resistance was defined as acquired non-susceptibility to at leas one agent in three or more antimicrobial categories.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Peking University Third Hospital	Beijing Chao Yang Hospital, Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of Maternal sepsis in intensive care unit	The incidence of Maternal sepsis in ICU represents as proportion based on the total number of of maternal ICU admissions and is expressed per 100 deliveries.	January 2008 to December 2019
Primary	Sepsis related maternal mortality	Sepsis related maternal mortality in hospitals represents as proportion based on the total number of maternal sepsis in intensive care units and is expressed per 100,000 deliveries.	January 2008 to December 2019
Primary	The incidence of multidrug resistance	The incidence of multidrug resistance represents as proportion based on the total number of of maternal sepsis in ICU and is expressed per 100 deliveries. Multidrug resistance was defined as acquired non-susceptibility to at leas one agent in three or more antimicrobial categories.	January 2008 to December 2019
Secondary	The length of ICU stay	The date of transferring to wards or death minus the date of ICU admission	January 2008 to December 2019
Secondary	Hospital length	Discharge date minus admission date	January 2008 to December 2019