Plain English Summary
Background and study aims
Obesity is a public health problem in the United States, with the state of Georgia leading the statistics as one of the regions with more cases of this complex problem. It is common knowledge that obesity in general, and morbid obesity in particular, lead to unwanted health consequences. On the other hand, pregnancy is a stressful period for the mother from the physiological standpoint. The combination of pregnancy and morbid obesity is a special situation in which both the mother and the fetus face challenges that may put their lives at risk. The risk is even higher when delivery involves a surgical procedure (cesarean section). Our study aimed to unravel the association between morbid obesity in mothers who underwent cesarean delivery at our institution. We explored the effects of obesity on complications related to surgery and anesthesia.
Who can participate?
Adult pregnant patients over the age of 18 with more than 37 weeks of gestation, with different body mass index values.
What does the study involve?
We conducted chart reviews to explore different aspects related to patient characteristics such as weight and gestational age and outcomes such as obstetric and anesthetic complications. The analysis looked back at the charts of patients who had already delivered at the moment of the study.
What are the possible benefits and risks of participating?
The benefits derived from our study will add to the existing knowledge about the association between obesity and obstetric complications. There are no known risks to participants taking part in this study, as we only reviewed medical records and patient personal information was protected following standards established by our institutional ethics committee.
Where is the study run from?
Department of Anesthesiology and Perioperative Medicine of Augusta University (USA)
When is the study starting and how long is it expected to run for?
January 2015 to March 2018
Who is funding the study?
Department of Anesthesiology and Perioperative Medicine of Augusta University (USA)
Who is the main contact?
Efrain Riveros Perez MD
eriverosperez@augusta.edu
Trial website
Contact information
Type
Scientific
Primary contact
Dr EFRAIN Riveros Perez
ORCID ID
http://orcid.org/0000-0002-3874-5783
Contact details
1120 15th Street BI-2144
Augusta
30912
United States of America
3304074681
efrainriveros@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1053583
Study information
Scientific title
Anesthetic and obstetric outcomes in morbidly obese pregnant patients undergoing cesarean delivery: retrospective analysis of a single-center experience
Acronym
Study hypothesis
Obstetric, anesthetic and neonatal complications in morbidly obese pregnant patients undergoing cesarean delivery are associated with the degree of obesity measured by BMI.
Ethics approval
Institutional Review Board at Augusta University, 05/04/2017, IRB approval #1053583
Study design
Observational retrospective cross-sectional chart review
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
No participant information sheet available
Condition
Cesarean section in morbidly obese pregnant patients
Intervention
Medical records from patients having cesarean section at Augusta University Medical Center during 2015 were retrieved from PowerChart information system and examined for inclusion criteria and study variables. After approval by the Institutional Review Board, we retrospectively studied obstetric patients who underwent cesarean section at Augusta University Medical Center between January 2011 and January 2016. Prenatal and outcome variables will be obtained from the health documentation system of Augusta University. For analysis purposes the patients will be divided into three groups based on body mass index:
1. Non-obese patients: BMI <30 kg/m²
2. Obese patients: BMI 30-39.9 kg/m²
3. Morbidly obese: BMI > 40 kg/m²
Variables that were collected include:
1. Demographic variables (maternal age, ASA status)
2. Morphometric measurements (BMI)
3. Maternal comorbidities
4. Prior cesarean sections
5. Information of pregnancy (gestational age, parity, prior cesarean deliveries, indication for cesarean section, obstetric comorbidities, emergent procedure)
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
1. Bleeding requiring transfusion, measured by quantification of collected blood and common surgical gauze, assessed during the operation
2. Wound infection, measured by visual inspection between surgery and discharge from the hospital
3. Maternal disposition, assessed using medical record notes at the end of surgery
4. Length of stay in hospital, assessed using medical record notes at the point of discharge from the hospital
5. Maternal mortality, assessed using medical record notes at the end of medical record closing
Secondary outcome measures
The following are assessed using medical record notes at the end of surgery@
1. Apgar scores
2. Birth weight
3. Anesthetic technique
4. Failed neuraxial block
5. Rate of conversion to general anesthesia
6. Phenylephrine dose
7. Anesthetic complications
Overall trial start date
01/01/2015
Overall trial end date
10/03/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Pregnant patients who underwent cesarean section at Augusta University Medical Center
2. Aged 18 years or over
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
771
Participant exclusion criteria
1. Gestational age <37 weeks
2. Patients with chronic pain conditions
Recruitment start date
01/02/2018
Recruitment end date
28/02/2018
Locations
Countries of recruitment
United States of America
Trial participating centre
Augusta University
1120 15th Street BI-2144
Augusta
30912
United States of America
Sponsor information
Organisation
Augusta university
Sponsor details
1120 15th Street BI-2144
Augusta
30912
United States of America
7067217361
eriverosperez@augusta.edu
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Self funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We intend to publish our results in the journal Annals of Medicine and Surgery
IPD sharing statement:
The Principal Investigator (Efrain Riveros-Perez, eriverosperez@augusta.edu) was responsible for the conduct of this study, including overseeing participant confidentiality, executing the Data and Safety Monitoring (DSM) plan, and complying with all reporting requirements to local and federal authorities. Since this is a database study uses already existing electronic health record data and does not involve direct patient care, we believe that a DSM Board is not needed. The only patient rights issue is maintaining confidentiality of the data. The data was abstracted from each patient’s electronic health record using their name and medical record number (MRN). The patient name and MRN was replaced by a patient study number for use in the analysis file. A separate file was used to maintain linking patient name and MRN with the patient study number. The analysis file might contain limited PHI information, such as dates of hospitalization.
Intention to publish date
01/08/2018
Participant level data
Available on request
Basic results (scientific)
Publication list