Epidemiological Investigation of Sepsis in Obstetrics Admitted to ICU

NCT ID: NCT05055388

Last Updated: 2021-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-03

Study Completion Date

2022-05-31

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.

Conditions

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Maternal Sepsis Intensive Care Units Drug Resistance, Multiple

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Multidrug-resistant bacteria

Intervention Type OTHER

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.

No interventions assigned to this group

Interventions

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Multidrug-resistant bacteria

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

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Beijing Chao Yang Hospital

OTHER

Sponsor Role collaborator

Beijing Friendship Hospital

OTHER

Sponsor Role collaborator

Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhao Zhiling

Deputy chief doctors

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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LM2020443

Identifier Type: -

Identifier Source: org_study_id

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