MedDataX Logo

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

NCT ID: NCT03002636

Last Updated: 2016-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cesarean Section

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Obesity Anesthesia Complications Body Mass Index (BMI)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Morbid Obesity group

Morbid Obesity group(n=300)

Group Type EXPERIMENTAL

anesthesia

Intervention Type PROCEDURE

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

severe Obesity group

severe Obesity group (n=300)

Group Type EXPERIMENTAL

anesthesia

Intervention Type PROCEDURE

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

non-Obesity group

non-Obesity group(n=300)

Group Type OTHER

anesthesia

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

anesthesia

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients with ASA Physical Status gradeΙΙ～ΙΙΙ.

Exclusion Criteria

* scoliosis, congenital heart disease, lung, liver, kidney diseases or increased intracranial pressure (ICP)
Minimum Eligible Age

24 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

International Peace Maternity and Child Health Hospital

OTHER

Sponsor Role collaborator

Fudan University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zeyong Yang

International Peace Maternity and Child Health Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yongtao Gao, MD

Role: STUDY_DIRECTOR

Shanghai Jiao Tong University School of Medicine

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 29049219 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IPMCH-anes

Identifier Type: -

Identifier Source: org_study_id