Transverse Supraumbilical Versus Pfannenstiel Incision for Cesarean Section in Morbidly Obese Women
1 other identifier
interventional
72
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2016
CompletedFirst Posted
Study publicly available on registry
February 26, 2016
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedFebruary 27, 2018
July 1, 2016
1.9 years
February 23, 2016
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
EXPERIMENTALtransverse 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.
pfannenstiel
ACTIVE COMPARATORPfannenstiel 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
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, 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.
Eligibility Criteria
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
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.
PMID: 41413498DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed M kotb, MD
Ain Shams University
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