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Clinical Trials/NCT03002636
NCT03002636
Completed
Not Applicable

Safety and Risk Assessment of Obese Parturient Underwent Cesarean Section(CS) Delivery Under General Anesthesia or Intraspinal Anesthesia

Fudan University0 sites900 target enrollmentJanuary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cesarean Section
Sponsor
Fudan University
Enrollment
900
Primary Endpoint
Patients numbers of obese parturient complications
Status
Completed
Last Updated
9 years ago

Overview

Brief 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.

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
September 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zeyong Yang

International Peace Maternity and Child Health Hospital

Shanghai Jiao Tong University School of Medicine

Eligibility Criteria

Inclusion Criteria

  • patients with ASA Physical Status gradeΙΙ~ΙΙΙ.

Exclusion Criteria

  • scoliosis, congenital heart disease, lung, liver, kidney diseases or increased intracranial pressure (ICP)

Outcomes

Primary Outcomes

Patients numbers of obese parturient complications

Time Frame: 2 years

Patients numbers of emergency, fetal macrosomia, gestational diabetes mellitus (GMD), CS history, fetal distress, elderly parturient women(≥35 years), prenatal fever, arrhythmias, abnormalities of the heart, hypertension(pre-eclampsia), multiple pregnancy, precious child, amniotic fluid abnormality, amout of bleeding, neonate Apgar's Score(1min), Apgar's Score(5min), and patients numbers of EA, GA, PACU (Postanesthesia Care Unit ) and ICU (Intensive Care Unit) for duration of hospital stay and anesthesia puncture times with 5\>n≥3 and n≥5 in three groups included non-Obesity group, severe Obesity group and Morbid Obesity group were also recorded. In addition, we also recorded puncture patients numbers in sitting position for all groups.

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