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

Fudan University logo

Fudan University

Status

Completed

Conditions

Cesarean Section

Treatments

Procedure: anesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT03002636
IPMCH-anes

Details and patient eligibility

About

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.

Full 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

Enrollment

900 patients

Sex

Female

Ages

24 to 35 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients with ASA Physical Status gradeΙΙ~ΙΙΙ.

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

900 participants in 3 patient groups

Morbid Obesity group
Experimental group
Description:
Morbid Obesity group(n=300)
Treatment:
Procedure: anesthesia
severe Obesity group
Experimental group
Description:
severe Obesity group (n=300)
Treatment:
Procedure: anesthesia
non-Obesity group
Other group
Description:
non-Obesity group(n=300)
Treatment:
Procedure: anesthesia

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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