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Low Versus High Transverse

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ClinicalTrials.gov Identifier: NCT03041220
Recruitment Status : Withdrawn (Per PI)
First Posted : February 2, 2017
Last Update Posted : September 8, 2017
Sponsor:
Information provided by (Responsible Party):
Heather Said, University of Nebraska

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Cesarean Section Procedure: cesarean section

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 Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Best Incision Site for Obese Patients - Low Versus High Transverse.
Study Start Date : December 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Groups and Cohorts
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Group/Cohort Intervention/treatment
cesarean section
Obese pregnant patients who have had a cesarean section.
 Procedure: cesarean section
obese patients (BMI of 30 or greater) who have had a cesarean section


Outcome Measures
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Primary Outcome Measures :
  1. Type of skin incision [ Time Frame: Delivery to 6 weeks postpartum ]
    Identify which type of skin incision has better outcomes in obese pregnant patients


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Ages between 18 - 45 years, female, and no limitation on ethnic background.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Vaginal delivery
Contacts and Locations
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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): NCT03041220


Sponsors and Collaborators
University of Nebraska
Investigators
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Principal Investigator: Heather Said, MD St. Louis University
More Information
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Responsible Party: Heather Said, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT03041220    
Other Study ID Numbers: 24387
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: September 8, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No