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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03590951
Other study ID # 1053583
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 3, 2017
Est. completion date February 13, 2018

Study information

Verified date July 2018
Source Augusta University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 771
Est. completion date February 13, 2018
Est. primary completion date February 13, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
United States Augusta University Augusta Georgia

Sponsors (1)

Lead Sponsor Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

Outcome

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