Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Anesthetic and Obstetric Outcomes in Morbidly Obese Pregnancy and Cesarean Delivery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03590951
Recruitment Status : Completed
First Posted : July 18, 2018
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Efrain Riveros Perez, MD, Augusta University

Brief Summary:
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).

Condition or disease Intervention/treatment
Morbid Obesity Cesarean Section Complications Pregnancy Related Other: Retrospective chart review

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 771 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Anesthetic and Obstetric Outcomes in Morbidly Obese Pregnant Patients Undergoing Cesarean Delivery: Retrospective Analysis of a Single Center Experience
Actual Study Start Date : May 3, 2017
Actual Primary Completion Date : February 13, 2018
Actual Study Completion Date : February 13, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section


Intervention Details:
  • Other: Retrospective chart review
    A retrospective chart review was conducted to evaluate the effect of body mass index on obstetric, anesthetic and neonatal complications in patients who underwent cesarean section at our institution


Primary Outcome Measures :
  1. Obstetric complications [ Time Frame: From beginning to end of cesarean section (2 hours) ]
    Perioperative bleeding


Secondary Outcome Measures :
  1. Anesthetic complications [ Time Frame: From beginning to end of cesarean section (2 hours) ]
    Failed epidural

  2. Neonatal complications [ Time Frame: 1 and 5 minutes after delivery ]
    Apgar scores

  3. Other anesthetic complications [ Time Frame: From beginning to end of cesarean section (2 hours) ]
    Intraoperative hypotension



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Term pregnant patients who underwent cesarean section between 2015 and 2016 at Augusta University Medical center.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03590951


Locations
Layout table for location information
United States, Georgia
Augusta University
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Augusta University
Investigators
Layout table for investigator information
Principal Investigator: Efrain Riveros Perez, MD Medical College of Georgia. Augusta University
Layout table for additonal information
Responsible Party: Efrain Riveros Perez, MD, Assistant Professor Department of Anesthesiology and Perioperative Medicine, Augusta University
ClinicalTrials.gov Identifier: NCT03590951    
Other Study ID Numbers: 1053583
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight