Epidemiological Investigation of Sepsis in Obstetrics Admitted to ICU

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Intensive Care Units; Drug Resistance, Multiple; Maternal Sepsis
• Intervention / Treatment: Other: Multidrug-resistant bacteria

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.

• Study Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Obstetrics with sepsis in any trimester of pregnancy or within 42 days of delivery

Description

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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Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group with sepsis complicated with multidrug-resistant bacteria; 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; Multidrug resistance was defined as acquired non-susceptibility to at leas one agent in three or more antimicrobial categories.
Group with sepsis complicated with none multidrug-resistant bacteria; 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?

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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: Beijing Friendship Hospital; Beijing Chao Yang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): May 31, 2022

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: September 14, 2021
• First Posted (Actual): September 24, 2021

Study Record Updates

• Last Update Posted (Actual): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pregnancy Complications; Sepsis; Toxemia; Pregnancy Complications, Infectious
• Other Study ID Numbers: LM2020443

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No