Epidemiological Investigation of Sepsis in Obstetrics Admitted to ICU

NCT05055388 — Unknown, 160 participants, Peking University Third Hospital

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

RegistryNCT05055388
StatusUnknown
Study typeObservational
Enrollment160 (Estimated)
SponsorPeking University Third Hospital (Other); collaborators: Beijing Chao Yang Hospital, Beijing Friendship Hospital
ConditionsMaternal Sepsis, Intensive Care Units, Drug Resistance, Multiple
InterventionsMultidrug-resistant bacteria (Other)
Datesstart 2020-12-03, primary completion 2021-12-31 (estimated), completion 2022-05-31 (estimated), first posted 2021-09-24, last updated 2021-09-24
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Maternal Sepsis All trials for Intensive Care Units All trials of Multidrug-resistant bacteria

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Group with sepsis complicated with multidrug-resistant bacteriaOther: Multidrug-resistant bacteriaObstetrics diagnosed with sepsis were divided to group with sepsis complicated with multidrug-resistant bacteria if microbial culture results showed multidrug-resistance.
Group with sepsis complicated with none multidrug-resistant bacteriaObstetrics diagnosed with sepsis were divided to group with sepsis complicated with none multidrug-resistant bacteria if microbial culture results showed none-multidrug-resistance or no positive result of microbial culture.
  • Multidrug-resistant bacteria (Other): Multidrug resistance was defined as acquired non-susceptibility to at leas one agent in three or more antimicrobial categories.

+Outcome measures

Primary outcomes

  • The incidence of Maternal sepsis in intensive care unit [January 2008 to December 2019]: 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.
  • Sepsis related maternal mortality [January 2008 to December 2019]: 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.
  • The incidence of multidrug resistance [January 2008 to December 2019]: 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.

Secondary outcomes

  • The length of ICU stay [January 2008 to December 2019]: The date of transferring to wards or death minus the date of ICU admission
  • Hospital length [January 2008 to December 2019]: Discharge date minus admission date

+Eligibility

Sex: Female, ages: 18 Years to 70 Years

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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+Locations (1)

FacilityCityCountryStatus
Peking University Third HospitalBeijing, Beijing MunicipalityChina