Best Incision Site for Obese Patients - Low Versus High Transverse

August 9, 2023 updated by: University of Nebraska
Retrospective chart review using both out patient and inpatient records of obese patients (BMI of 30 or greater) who have had a cesarean section since the year 2009. We will evaluate the patient's BMI, their skin incision type at time of c-section, their co-morbidities, number of previous c-sections and post partum follow up for wound infection, wound separation and wound breakdown. We will also review operative notes to evaluate blood loss, length of surgery and complications during surgery. We will obtain maternal characteristics and information about the pregnancy.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Past studies have looked primarily at vertical vs low transverse skin incision. There is data that performing a high transverse skin incision on obese patients leads to better visualization and less wound infection but there are few studies comparing it directly to low transverse skin incision.

Retrospective chart review of obese patient's who have had a cesarean section at St Mary's hospital by either a low or high transverse skin incision between January 1, 2009 - July 31, 2014. We will review charts up to 6 week postpartum.

Pregnancies will be identified through identifing those who have cesarean sections. They will be narrowed down by those who have BMI of > 30. Maternal prenatal records, postnatal records and delivery records will be reviewed.

Study Type

Observational

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 to 45 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Ages between 18 - 45 years, female, and no limitation on ethnic background.

Description

Inclusion Criteria:

  • obese patients (BMI of 30 or greater) who have had a cesarean section

Exclusion Criteria:

  • Vaginal delivery

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cesarean section
Obese pregnant patients who have had a cesarean section.
obese patients (BMI of 30 or greater) who have had a cesarean section

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type of skin incision
Time Frame: Delivery to 6 weeks postpartum
Identify which type of skin incision has better outcomes in obese pregnant patients
Delivery to 6 weeks postpartum

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Heather Said, MD, St. Louis 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 (Estimated)

December 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

January 11, 2017

First Submitted That Met QC Criteria

February 1, 2017

First Posted (Estimated)

February 2, 2017

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 9, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 24387

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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