Augusta, Georgia 30912

  • Pregnancy Related

Purpose:

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 summary:

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.


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


Study is Available At:


Original ID:

1053583


NCT ID:

NCT03590951


Secondary ID:


Study Acronym:


Brief Title:

Anesthetic and Obstetric Outcomes in Morbidly Obese Pregnancy and Cesarean Delivery


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Augusta University


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

771


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:May 3, 2017
Completion Date:February 13, 2018
Completion Type:Actual
Primary Completion Date:February 13, 2018
Primary Completion Type:Actual
Verification Date:July 2018
Last Changed Date:July 17, 2018
First Received Date:July 5, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Other anesthetic complications
Time Frame:From beginning to end of cesarean section (2 hours)
Safety Issues:False
Description:Intraoperative hypotension
Outcome Type:Secondary Outcome
Measure:Neonatal complications
Time Frame:1 and 5 minutes after delivery
Safety Issues:False
Description:Apgar scores
Outcome Type:Secondary Outcome
Measure:Anesthetic complications
Time Frame:From beginning to end of cesarean section (2 hours)
Safety Issues:False
Description:Failed epidural
Outcome Type:Primary Outcome
Measure:Obstetric complications
Time Frame:From beginning to end of cesarean section (2 hours)
Safety Issues:False
Description:Perioperative bleeding

Study Interventions

Intervention Type:Other
Name:Retrospective chart review
Description: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

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Augusta University

Samples and Retentions

Study Population: Term pregnant patients who underwent cesarean section between 2015 and 2016 at Augusta University Medical center.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 26, 2021

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