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NCT Number: NCT04657692

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

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.

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Key information

Conditions

Cesarean Section Complications Anesthesia Complication Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Patchareya Nivatpumin

Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anesthesia; general or regional

Procedure

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

Primary outcomes

  1. Incidence of complications

    Time frame: intraoperative period to 24 hours postoperative

    Incidence of maternal complications associated with anesthesia

Secondary outcomes

  1. 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

  2. Neonatal outcomes

    Time frame: Neonate apgar score at 1-min and 5 min

    Neonate apgar score (ranging 0-10)

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 8, 2020
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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