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

NCT03002636 | Completed DMC

• 1 other identifier: IPMCH-anes
• Study Type: interventional
• Target: 900
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cesarean Section

Keywords

Obesity; Anesthesia Complications; Body Mass Index (BMI)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Morbid Obesity group

EXPERIMENTAL

Morbid Obesity group(n=300)

Procedure: anesthesia

severe Obesity group

EXPERIMENTAL

severe Obesity group (n=300)

Procedure: anesthesia

non-Obesity group

OTHER

non-Obesity group(n=300)

Procedure: anesthesia

Interventions

anesthesia PROCEDURE

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

Morbid Obesity group; non-Obesity group; severe Obesity group

Eligibility Criteria

• Age: 24 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients with ASA Physical Status gradeΙΙ～ΙΙΙ.

You may not qualify if:

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

Sponsors & Collaborators

• Fudan University: lead
• International Peace Maternity and Child Health Hospital: collaborator

Related Publications (1)

• An X, Zhao Y, Zhang Y, Yang Q, Wang Y, Cheng W, Yang Z. Risk assessment of morbidly obese parturient in cesarean section delivery: A prospective, cohort, single-center study. Medicine (Baltimore). 2017 Oct;96(42):e8265. doi: 10.1097/MD.0000000000008265.

  PMID: 29049219 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Anesthesia

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• Yongtao Gao, MD

  Shanghai Jiao Tong University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: International Peace Maternity and Child Health Hospital

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 26, 2016
• Study Start: January 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 26, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share