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

NCT ID: NCT02692729

Last Updated: 2018-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

transverse supraumbilical

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

pfannenstiel incision

Intervention Type PROCEDURE

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.

Interventions

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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

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* patients receiving steroids or anticoagulation
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed El Kotb Abdel Fattah

dr. Ahmed Kotb

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed M kotb, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

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Faculty of Medicine, Ain Shams University

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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STIP

Identifier Type: -

Identifier Source: org_study_id

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