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

Not Applicable

Completed

• Conditions: Cesarean Section
• Interventions: Procedure: anesthesia

• Registration Number: NCT03002636
• Lead Sponsor: Fudan University

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

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2016-01
• Study Completion: 2016-09
• Status Verified: 2016-12
• Study First Submitted: 2016-12-07
• Study First Submitted QC: 2016-12-21
• Last Update Submitted: 2016-12-21
• Study First Posted: 2016-12-26
• Last Update Posted: 2016-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 900

Inclusion Criteria

• patients with ASA Physical Status gradeΙΙ～ΙΙΙ.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
non-Obesity group	anesthesia	non-Obesity group(n=300)
severe Obesity group	anesthesia	severe Obesity group (n=300)
Morbid Obesity group	anesthesia	Morbid Obesity group(n=300)

Primary Outcome Measures

Name	Time	Method
Patients numbers of obese parturient complications	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.