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

NCT ID: NCT04657692

Last Updated: 2023-04-11

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

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Recruitment Status

COMPLETED

Total Enrollment

527 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-29

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cesarean Section Complications Anesthesia Complication Obesity, Morbid

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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Anesthesia; general or regional

General anesthesia: general anesthesia with endotracheal tube Regional anesthesia: spinal anesthesia, epidural anesthesia, combined spinal epidural anesthesia

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patchareya Nivatpumin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University

Locations

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Patchareya Nivatpumin

Bangkok, , Thailand

Site Status

Countries

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Thailand

References

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Nivatpumin P, Lertbunnaphong T, Maneewan S, Vittayaprechapon N. Comparison of perioperative outcomes and anesthetic-related complications of morbidly obese and super-obese parturients delivering by cesarean section. Ann Med. 2023 Dec;55(1):1037-1046. doi: 10.1080/07853890.2023.2187877.

Reference Type RESULT
PMID: 36947155 (View on PubMed)

Other Identifiers

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Si 125/2020

Identifier Type: OTHER

Identifier Source: secondary_id

873/2562 (EC2)

Identifier Type: -

Identifier Source: org_study_id

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