NCT02692729

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

February 27, 2018

Status Verified

July 1, 2016

Enrollment Period

1.9 years

First QC Date

February 23, 2016

Last Update Submit

February 25, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • occurence of surgical site infection

    occurance of redness, hotness, pus discharge and exudation

    one week

Secondary Outcomes (2)

  • operative time in minutes

    2 hours

  • blood loss in milliliter

    2 hours

Study Arms (2)

supraumbilical transverse

EXPERIMENTAL

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

pfannenstiel

ACTIVE COMPARATOR

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

Interventions

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

supraumbilical transverse

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.

pfannenstiel

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • patients receiving steroids or anticoagulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Ain Shams University

Cairo, Cairo Governorate, Egypt

Location

Related Publications (1)

  • AbdElhady RM, Hamid ASA, El Sayed HM, El Mekkawi SF, Elhossary HMAF, El Kotb AM. Randomized trial assessing transverse supraumbilical incisions for cesarean sections in morbid obese women with pannus. BMC Pregnancy Childbirth. 2025 Dec 18. doi: 10.1186/s12884-025-08530-y. Online ahead of print.

Study Officials

  • Ahmed M kotb, MD

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr. Ahmed Kotb

Study Record Dates

First Submitted

February 23, 2016

First Posted

February 26, 2016

Study Start

March 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

February 27, 2018

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations