NCT04657692

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
527

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2020

Completed
21 days until next milestone

Study Start

First participant enrolled

December 29, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 11, 2023

Status Verified

April 1, 2023

Enrollment Period

10 months

First QC Date

December 1, 2020

Last Update Submit

April 10, 2023

Conditions

Keywords

anesthetic complicationsmaternal outcomesneonatal outcomescesarean sectionobesity

Outcome Measures

Primary Outcomes (1)

  • Incidence of complications

    Incidence of maternal complications associated with anesthesia

    intraoperative period to 24 hours postoperative

Secondary Outcomes (2)

  • Incidence of obstetric-related complications

    intraoperative period to 24 hours postoperative

  • Neonatal outcomes

    Neonate apgar score at 1-min and 5 min

Interventions

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Obese pregnant women whose body mass index (BMI\>,= 40 kg/m2) underwent cesarean delivery

You may qualify if:

  • Pregnant women BMI\>,= 40 kg/m2 underwent cesarean delivery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Patchareya Nivatpumin

Bangkok, 10700, Thailand

Location

Related 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: 10.1080/07853890.2023.2187877.

MeSH Terms

Conditions

Obesity, MorbidObesity

Interventions

AnesthesiaAmino Acid Motifs

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and AnalgesiaProtein Structural ElementsProtein ConformationMolecular ConformationMolecular StructureBiochemical PhenomenaChemical PhenomenaProtein Structure, Secondary

Study Officials

  • Patchareya Nivatpumin, M.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2020

First Posted

December 8, 2020

Study Start

December 29, 2020

Primary Completion

October 31, 2021

Study Completion

December 31, 2021

Last Updated

April 11, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations