Clinical trial NCT05055388: Epidemiological Investigation of Sepsis in Obstetrics Admitted to ICU
Official title: Epidemiological Investigation of Sepsis in Obstetrics Admitted to ICU From 2008 to 2016 in Beijing China: A First Multicenter Report
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Maternal Sepsis
Intensive Care Units
Drug Resistance, Multiple
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Chao Yang Hospital
name: Beijing Friendship Hospital
First posted: 2021-09-24
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obstetrics with sepsis in any trimester of pregnancy or within 42 days of delivery

Brief 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.

Detailed 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.

Eligibility criteria: 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.

-

Primary outcomes:
measure: The incidence of Maternal sepsis in intensive care unit
timeFrame: January 2008 to December 2019
measure: Sepsis related maternal mortality
timeFrame: January 2008 to December 2019
measure: The incidence of multidrug resistance
timeFrame: January 2008 to December 2019
Secondary outcomes:
measure: The length of ICU stay
timeFrame: January 2008 to December 2019
measure: Hospital length
timeFrame: January 2008 to December 2019
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References: