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

Comparison Between Vertical Splitting Versus Transverse Cutting of Muscle Layer in Lower Segment Cesarean Sections to Avoid Uterine Vessels Injury: a Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Cesarean Section Complications
• Intervention / Treatment: Procedure: Transverse cutting; Procedure: vertical splitting

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 Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11311
    • Ahmed Abass

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Transverse splitting; transverse cutting and/or pulling of lower uterine segment during lower segment cesarean section.	Procedure: Transverse cutting; Transverse cutting and/or pulling.of lower uterine segment during lower cesarean section extending the uterine incision laterally.
Active Comparator: Vertical splitting; vertical splitting,of lower uterine segment during lower segment cesarean section.	Procedure: vertical splitting; vertical splitting of lower uterine segment during lower cesarean section making the direction of traction up and downward instead of being laterally and we suppose that this will allow 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
uterine incision extension	the surgeon performing the cesarean section will detect if uterine incision extension occurred or not after extraction of the baby and the placenta.	2 minutes extraction of the baby and placenta
intra-operative blood loss	blood loss will be assessed by circulating nurse through counting soaked surgical towels and gauze and calculating estimated blood loss in vacation suction system.	before closure of the abdominal wall layer
postpartum hemorrhage	will be defined by postpartum blood loss of 1000cc	first 24 hours after delivery
postoperative pain	pain scale from 0 to 10 to assess postoperative pain after delivery	2 hours after delivery
postoperative pain	pain scale from 0 to 10 to assess postoperative pain at hours 2 after delivery	6 hours after delivery
postoperative pain	pain scale from 0 to 10 to assess postoperative pain at hours 2 after delivery	12 hours after delivery
postoperative pain	pain scale from 0 to 10 to assess postoperative pain at hours 2 after delivery	24 hours after delivery

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Waled Hitler, Prof, Ainshams university

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: July 15, 2017
• First Submitted That Met QC Criteria: July 18, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 16, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: injury; Cesarean Section Complications; vertical splitting; uterine vessels
• Other Study ID Numbers: Vertical splitting in CS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No