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

February 25, 2018 updated by: Ahmed Mohamed El Kotb Abdel Fattah, Ain Shams University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Al Qahirah
      • Cairo, Al Qahirah, Egypt
        • Faculty of Medicine, Ain Shams University

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

14 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • BMI more than 40 kg/m2
  • women scheduled for CS

Exclusion Criteria:

  • patients receiving steroids or anticoagulation

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: supraumbilical transverse
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. Above the panniculus, the fatty tissues are not particularly thick. A transverse opening of the aponeurosis and of the parietal peritoneum was done. Then the approach to the lower uterine segment was easy. A Ricard retractor was put in place.
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
Active Comparator: pfannenstiel
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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
occurence of surgical site infection
Time Frame: one week
occurance of redness, hotness, pus discharge and exudation
one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operative time in minutes
Time Frame: 2 hours
from skin incision to closure of the skin
2 hours
blood loss in milliliter
Time Frame: 2 hours
volume of blood during the operation
2 hours

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Ahmed M kotb, MD, Ain Shams 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 (Actual)

March 1, 2016

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

February 23, 2016

First Submitted That Met QC Criteria

February 23, 2016

First Posted (Estimate)

February 26, 2016

Study Record Updates

Last Update Posted (Actual)

February 27, 2018

Last Update Submitted That Met QC Criteria

February 25, 2018

Last Verified

July 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • STIP

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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