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NCT02692729 Clinical Trial

Transverse Supraumbilical Versus Pfannenstiel Incision for Cesarean Section in Morbidly Obese Women

Cesarean Section Clinical Trial

Official title:
Transverse Supraumbilical Versus Pfannenstiel Incision For Cesarean Section in Morbid Obese Patients" A Single Blinded Randomized Controlled Trial"

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02692729
Other study ID # STIP
Secondary ID
Status Completed
Phase N/A
First received February 23, 2016
Last updated February 25, 2018
Start date March 2016
Est. completion date February 2018

Study information
Verified date July 2016
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to evaluate the efficacy and safety of transverse supraumbilical incision over Pfannenstiel incision in performing cesarean section for morbid obese pregnant women.

Description:

Research Question In Morbidly obese women undergoing cesarean section, is transverse supraumbilical incision superior to Pfannenstiel incision? Research Hypothesis Transverse supraumbilical incision is superior to Pfannenstiel incision in morbidly obese women undergoing cesarean section.

Recruitment information / eligibility
Status Completed
Enrollment 72
Est. completion date February 2018
Est. primary completion date February 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- BMI more than 40 kg/m2

- women scheduled for CS

Exclusion Criteria:

- patients receiving steroids or anticoagulation

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• transverse supraumbilical
transverse Supraumbilical Incision, in which the skin incision is a straight transverse skin incision slightly higher than the Pfannenstiel (5- 6) cm. from the upper border of the symphysis pubis The high transverse incision facilitated access to the fascia of the rectus abdominalis
• pfannenstiel incision
Pfannenstiel Incision, in which the skin incision is a transverse upward concavity, typically initiated two finger-breadths above the symphysis pubis and extended in the direction of the anterior superior iliac spine below and medial to it about (2 - 3 ) cm.

Locations
Country Name City State
Egypt Faculty of Medicine, Ain Shams University Cairo Al Qahirah

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary occurence of surgical site infection occurance of redness, hotness, pus discharge and exudation one week
Secondary operative time in minutes from skin incision to closure of the skin 2 hours
Secondary blood loss in milliliter volume of blood during the operation 2 hours
See also
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Recruiting NCT06247852 - Persistent Pain After Cesarean Delivery - A Danish Multicenter Cohort Study
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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