Incidence of Complications Associated With Anesthesia in Obesity Parturient Undergoing Cesarean Delivery

April 10, 2023 updated by: Mahidol University

Incidence of Complications Associated With Anesthesia in Obesity Parturient Undergoing Cesarean Delivery- a Retrospective Review

The incidence of obesity parturient has been increasing worldwide. There was a report revealing one third of pregnant women in United state considered obesity.

Obesity is associated with increased in maternal and neonatal complications. Also, there was an increasing in the rate of cesarean delivery. Anesthetic management of the obese parturient is differ from non-obese parturients. There were higher risk of difficult intubation, failed intubation, pulmonary aspiration and difficult regional anesthesia such as spinal anesthesia or epidural catheter placement comparing with non-obese parturient.

The aim of the study is to report complication associated with anesthesia in obese patients undergoing cesarean delivery in Single University hospital, Bangkok, THAILAND.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The incidence of obesity parturient has been increasing worldwide. There was a report revealing one third of pregnant women in United state considered obesity.

Obesity is associated with increased in maternal and neonatal complications. Also, there was an increasing in the rate of cesarean delivery. Anesthetic management of the obese parturient is differ from non-obese parturients. There were higher risk of difficult intubation and difficult regional anesthesia such as spinal anesthesia or epidural catheter placement comparing with non-obese parturient.

WHO categorised obesity into 3 classification; grade 1: BMI 30-34.9 kg/m2, grade 2: BMI 35-39.9 kg/m2, grade 3: BMI > 40 kg/m2. This study emphasised in grade 3 obese pregnant women (BMI>40 kg/m2) undergoing cesarean delivery that were at risk of increasing in anesthetic complications such as airway complications as well as complications derived from regional anesthesia eg. high spinal block, failed spinal block etc.

Therefore, the primary objective of the study is to report complication associated with anesthesia in obese patients undergoing cesarean delivery in Single University hospital, Bangkok, THAILAND. The secondary objectives rate of postpartum haemorrhage, rate of hysterectomy and neonatal outcomes.

Study Type

Observational

Enrollment (Actual)

527

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Patchareya Nivatpumin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Obese pregnant women whose body mass index (BMI>,= 40 kg/m2) underwent cesarean delivery

Description

Inclusion Criteria:

  • Pregnant women BMI>,= 40 kg/m2 underwent cesarean delivery

Exclusion Criteria:

  • Patients with gestational age <,= 24 weeks
  • Patients with death fetus in Utero
  • Multiple gestation
  • Patients with intrapelvic cavity pathology eg. myoma uteri
  • Patients with abnormal placentation
  • Patients with polyhydramnios

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of complications
Time Frame: intraoperative period to 24 hours postoperative
Incidence of maternal complications associated with anesthesia
intraoperative period to 24 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of obstetric-related complications
Time Frame: intraoperative period to 24 hours postoperative
Incidence of maternal complicaitions associated with obstetrics eg. amount of hemorrhage, rate of hysterectomy, rate of blood transfusion
intraoperative period to 24 hours postoperative
Neonatal outcomes
Time Frame: Neonate apgar score at 1-min and 5 min
Neonate apgar score (ranging 0-10)
Neonate apgar score at 1-min and 5 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Patchareya Nivatpumin, M.D., Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2020

Primary Completion (Actual)

October 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

December 1, 2020

First Submitted That Met QC Criteria

December 1, 2020

First Posted (Actual)

December 8, 2020

Study Record Updates

Last Update Posted (Actual)

April 11, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 873/2562 (EC2)
  • Si 125/2020 (Other Identifier: Siriraj Institutional Review Board)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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