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Safety and Risk Assessment of Obese Parturient Underwent Cesarean Section(CS) Delivery Under Different Anesthesia Ways

NCT03002636 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2016-12-26

No results posted yet for this study

Summary

900 parturient who underwent CS under general anesthesia(GA) , intraspinal anesthesia included epidural anesthesia(EA) and combined spinal-epidural anesthesia(CSEA), which were divided into 3 groups: Morbid Obesity group (n=300) with body mass index (BMI) \>40 kg/m2 , severe Obesity group (n=300) with 30 kg/m2≤BMI ≤40 kg/m2 and non-Obesity group(n=300) with BMI\<30 kg/m2. Findings Between January 1, 2013 and September 30, 2016, a total of 1000 women met inclusion criteria and 900 women received allocated intervention. All patients were divided into three groups: Morbid Obesity group(n=300), Severe Obesity group(n=300) and non-Obesity group(n=300) according to body mass index (BMI) \>40 kg/m2, 30 kg/m2≤BMI ≤40 kg/m2 and BMI\<30 kg/m2.900 patients completed the protocol and related data were analysed.

Conditions

  • Cesarean Section

Interventions

PROCEDURE

anesthesia

Anesthesia : (1) General Anesthesia (GA)(2) Epidural Anesthesia (EA) (3) Combined Spinal-Epidural Anesthesia (CSEA)

Sponsors & Collaborators

  • International Peace Maternity and Child Health Hospital

    collaborator OTHER

  • Fudan University

    lead OTHER

Principal Investigators

  • Yongtao Gao, MD · Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
24 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2016-01-31
Completion
2016-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03002636 on ClinicalTrials.gov