Epidemiological Investigation of Sepsis in Obstetrics Admitted to ICU

NCT05055388 | Unknown

• 1 other identifier: LM2020443
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Maternal Sepsis; Intensive Care Units; Drug Resistance, Multiple

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• The length of ICU stay

  January 2008 to December 2019

• Hospital length

  January 2008 to December 2019

Study Arms (2)

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

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.

Interventions

Multidrug-resistant bacteria 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 multidrug-resistant bacteria

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Beijing Chao Yang Hospital: collaborator
• Beijing Friendship Hospital: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Pregnancy Complications, Infectious

Condition Hierarchy (Ancestors)

Infections; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief doctors

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: September 24, 2021
• Study Start: December 3, 2020
• Primary Completion: December 31, 2021
• Study Completion: May 31, 2022
• Last Updated: September 24, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)