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

Obesity, Morbid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04657692
• Other study ID #: 873/2562 (EC2)
• Secondary ID: Si 125/2020
• Status: Completed
• Start date: December 29, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2023
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 527
• Est. completion date: December 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia Complication
• Cesarean Section Complications
• Obesity
• Obesity, Morbid

Intervention

Procedure:
• Anesthesia; general or regional
General anesthesia: general anesthesia with endotracheal tube Regional anesthesia: spinal anesthesia, epidural anesthesia, combined spinal epidural anesthesia

Locations

Country	Name	City	State
Thailand	Patchareya Nivatpumin	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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: — View Citation

Outcome

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