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

Completed

• Conditions: Anesthesia Complication; Cesarean Section Complications; Obesity, Morbid

• Registration Number: NCT04657692
• Lead Sponsor: Mahidol University

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-12-01
• Study First Submitted QC: 2020-12-01
• Study First Posted: 2020-12-08
• Study Start: 2020-12-29
• Primary Completion: 2021-10-31
• Study Completion: 2021-12-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 527

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of complications	intraoperative period to 24 hours postoperative	Incidence of maternal complications associated with anesthesia

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Patchareya Nivatpumin; 🇹🇭 Bangkok, Thailand