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NCT03041220 Clinical Trial

Best Incision Site for Obese Patients - Low Versus High Transverse

Cesarean Section Clinical Trial

Official title:
Best Incision Site for Obese Patients - Low Versus High Transverse

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03041220
Other study ID # 24387
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date December 2016
Est. completion date December 2016

Study information
Verified date August 2023
Source University of Nebraska
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - obese patients (BMI of 30 or greater) who have had a cesarean section Exclusion Criteria: - Vaginal delivery

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Nebraska

Outcome
Type Measure Description Time frame Safety issue
Primary Type of skin incision Identify which type of skin incision has better outcomes in obese pregnant patients Delivery to 6 weeks postpartum
See also
  Status Clinical Trial Phase
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Completed NCT00375986 - A Comparison of Manual vs. Spontaneous Removal of the Placenta at Cesarean Section N/A
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Completed NCT00517140 - Vaginal Birth After Caesarean Section - Effect on Maternal Psychosocial Function N/A
Terminated NCT05051150 - Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Caesarean Section Phase 4
Terminated NCT03695172 - Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section Phase 4
Recruiting NCT06247852 - Persistent Pain After Cesarean Delivery - A Danish Multicenter Cohort Study
Completed NCT06012747 - Pain After Cesarean Section - A Danish Multicenter Cohort Study.
Not yet recruiting NCT05187520 - Naldebain for Control of Post-Cesarean Section Pain Phase 2
Not yet recruiting NCT04999670 - Fascial Closure and Post-caesarean Pain N/A