Clinical trial NCT04657692: Incidence of Complications Associated With Anesthesia in Obesity Parturient Undergoing Cesarean Delivery
Official title: Incidence of Complications Associated With Anesthesia in Obesity Parturient Undergoing Cesarean Delivery- a Retrospective Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Section Complications
Anesthesia Complication
Obesity, Morbid
Keywords: anesthetic complications
maternal outcomes
neonatal outcomes
cesarean section
obesity
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2020-12-08
Enrollment: 527
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese pregnant women whose body mass index (BMI\>,= 40 kg/m2) underwent cesarean delivery

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of complications
timeFrame: intraoperative period to 24 hours postoperative
Secondary outcomes:
measure: Incidence of obstetric-related complications
timeFrame: intraoperative period to 24 hours postoperative
measure: Neonatal outcomes
timeFrame: Neonate apgar score at 1-min and 5 min
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Patchareya Nivatpumin
Study officials:
affiliation: Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University
name: Patchareya Nivatpumin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.