NCT03590951

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
771

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

10 months

First QC Date

July 5, 2018

Last Update Submit

July 17, 2018

Conditions

Morbid ObesityCesarean Section ComplicationsPregnancy Related

Outcome Measures

Primary Outcomes (1)

  • Obstetric complications

    Perioperative bleeding

    From beginning to end of cesarean section (2 hours)

Secondary Outcomes (3)

  • Anesthetic complications

    From beginning to end of cesarean section (2 hours)

  • Neonatal complications

    1 and 5 minutes after delivery

  • Other anesthetic complications

    From beginning to end of cesarean section (2 hours)

Interventions

Retrospective chart reviewOTHER

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Augusta University

Augusta, Georgia, 30912, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Efrain Riveros Perez, MD

    Medical College of Georgia. Augusta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Department of Anesthesiology and Perioperative Medicine

Study Record Dates

First Submitted

July 5, 2018

First Posted

July 18, 2018

Study Start

May 3, 2017

Primary Completion

February 13, 2018

Study Completion

February 13, 2018

Last Updated

July 18, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)