Condition category
Pregnancy and Childbirth
Date applied
02/07/2018
Date assigned
17/10/2018
Last edited
24/10/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

www.augusta.edu

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

Publication citations

Additional files

Editorial Notes

24/10/2018: Internal review.