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

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03002636
• Other study ID #: IPMCH-anes
• Status: Completed
• Phase: N/A
• First received: December 7, 2016
• Last updated: December 21, 2016
• Start date: January 2013
• Est. completion date: September 2016

Study information

• Verified date: December 2016
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Science and Technology Commission of Shanghai Municipality
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: September 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 24 Years to 35 Years

Eligibility

Inclusion Criteria:

• patients with ASA Physical Status grade??~???.

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cesarean Section

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Fudan University	International Peace Maternity and Child Health Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients numbers of obese parturient complications	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.	2 years	Yes