Epidemiological Investigation of Sepsis in Obstetrics Admitted to ICU

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Drug Resistance, Multiple, Maternal Sepsis, Intensive Care Units

Intervention / Treatment
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* Other: Multidrug-resistant bacteria


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group with sepsis complicated with multidrug-resistant bacteria<br>Obstetrics diagnosed with sepsis were divided to group with sepsis complicated with multidrug-resistant bacteria if microbial culture results showed multidrug-resistance. | Other: Multidrug-resistant bacteria<br>* Multidrug resistance was defined as acquired non-susceptibility to at leas one agent in three or more antimicrobial categories.<br>|
| Group with sepsis complicated with none multidrug-resistant bacteria<br>Obstetrics 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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The length of ICU stay | The date of transferring to wards or death minus the date of ICU admission | January 2008 to December 2019 | 
| Hospital length | Discharge date minus admission date | January 2008 to December 2019 |