Anesthetic and Obstetric Outcomes in Morbidly Obese Pregnancy and Cesarean Delivery

July 17, 2018 updated by: Efrain Riveros Perez, MD, Augusta University

Anesthetic and Obstetric Outcomes in Morbidly Obese Pregnant Patients Undergoing Cesarean Delivery: Retrospective Analysis of a Single Center Experience

Given that morbid obesity has been strongly associated with obstetric, neonatal and anesthetic complications, and that scarce reports have evaluated anesthetic and obstetric outcomes after cesarean delivery in morbidly obese patients; This study retrospectively analyzed anesthetic, obstetric and neonatal outcomes in morbidly obese pregnant patients who underwent cesarean delivery at Augusta University Medical Center, during a 2-year period (2015-2016).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study compared non-obese, obese and morbidly obese patients with respect to maternal, perinatal and anesthetic outcomes. Obstetric aspects included emergent procedure, estimated blood loss, obstetric complications, maternal disposition, length of stay and in-hospital mortality. Neonatal aspects included Apgar scores. Anesthetic aspects included anesthetic technique, intraoperative hemodynamic instability, failed regional anesthesia and anesthetic complications.

Study Type

Observational

Enrollment (Actual)

771

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Augusta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Term pregnant patients who underwent cesarean section between 2015 and 2016 at Augusta University Medical center.

Description

Inclusion Criteria:

  • Pregnant patients who underwent cesarean section at Augusta University Medical Center.
  • Patients older than 18 years.

Exclusion Criteria:

  • Gestational age <37 weeks.
  • Patients with chronic pain conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Obstetric complications
Time Frame: From beginning to end of cesarean section (2 hours)
Perioperative bleeding
From beginning to end of cesarean section (2 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anesthetic complications
Time Frame: From beginning to end of cesarean section (2 hours)
Failed epidural
From beginning to end of cesarean section (2 hours)
Neonatal complications
Time Frame: 1 and 5 minutes after delivery
Apgar scores
1 and 5 minutes after delivery
Other anesthetic complications
Time Frame: From beginning to end of cesarean section (2 hours)
Intraoperative hypotension
From beginning to end of cesarean section (2 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Augusta University

Investigators

  • Principal Investigator: Efrain Riveros Perez, MD, Medical College of Georgia. Augusta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2017

Primary Completion (Actual)

February 13, 2018

Study Completion (Actual)

February 13, 2018

Study Registration Dates

First Submitted

July 5, 2018

First Submitted That Met QC Criteria

July 17, 2018

First Posted (Actual)

July 18, 2018

Study Record Updates

Last Update Posted (Actual)

July 18, 2018

Last Update Submitted That Met QC Criteria

July 17, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1053583

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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