Vertical Splitting of Muscle Layer in Lower Segment Cesarean Sections to Avoid Uterine Vessels Injury

Not Applicable

• Conditions: Cesarean Section Complications
• Interventions: Procedure: vertical splitting; Procedure: Transverse cutting

• Registration Number: NCT03224247
• Lead Sponsor: Ain Shams University

Brief Summary

Cesarean section is one of the oldest surgical interventions in the history of medicine.Many variations in cesarean section technique have been studied.The investigatory team are aiming to decrease blood loss during cesarean section by vertical splitting versus transverse cutting of muscle layer in lower segment cesarean sections to avoid uterine vessels injury.

Detailed Description

Cesarean section is one of the oldest surgical interventions in the history of medicine.Since the first documented cesarean delivery in 1020 AD, various modifications have been made in the technique. It was a surgery performed as a last resort, mostly peri- or post-portem.

Many variations in cesarean section technique have been studied.our study aim is to decrease blood loss during cesarean section through decreasing incidence of uterine vessels injury. The investigator supposed that applying Vertical pull on a small C-shaped incision in the lower uterine segment during cesarean section allows the tissues to split along their natural arrangement, decreasing the probability of extension of the wound into the uterine vessels, thus; decreasing blood loss; operative time and maternal recovery.

Study Timeline

• Study First Submitted: 2017-07-15
• Study First Submitted QC: 2017-07-18
• Study First Posted: 2017-07-21
• Status Verified: 2021-01
• Study Start: 2021-01-01
• Last Update Submitted: 2021-01-16
• Last Update Posted: 2021-01-20
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

• Elective cesarean section
• No medical disorders during pregnancy ( Hypertension, DM , ..)
• No coagulation disorders either congenital nor acquired.

Exclusion Criteria

• Urgent or emergency cesarean section.
• Multiple pregnancy.
• Presence of medical disorders during pregnancy ( Hypertension, DM , ..)
• Presence of coagulation disorders either congenital nor acquired.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vertical splitting	vertical splitting	vertical splitting,of lower uterine segment during lower segment cesarean section.
Transverse splitting	Transverse cutting	transverse cutting and/or pulling of lower uterine segment during lower segment cesarean section.

Primary Outcome Measures

Name	Time	Method
Uterine vessels injury	1 minute after extraction of the baby and placenta	the surgeon performing the cesarean section will detect if injury of uterine vessels occurred or not while extending uterine incision.

Secondary Outcome Measures

Name	Time	Method
postoperative pain	24 hours after delivery	pain scale from 0 to 10 to assess postoperative pain at hours 2 after delivery
postpartum hemorrhage	first 24 hours after delivery	will be defined by postpartum blood loss of 1000cc
uterine incision extension	2 minutes extraction of the baby and placenta	the surgeon performing the cesarean section will detect if uterine incision extension occurred or not after extraction of the baby and the placenta.
intra-operative blood loss	before closure of the abdominal wall layer	blood loss will be assessed by circulating nurse through counting soaked surgical towels and gauze and calculating estimated blood loss in vacation suction system.

Trial Locations

Locations (1)

Ahmed Abass; 🇪🇬 Cairo, Egypt