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

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03224247
• Other study ID #: Vertical splitting in CS
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: January 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

Procedure:
• Transverse cutting
Transverse cutting and/or pulling.of lower uterine segment during lower cesarean section extending the uterine incision laterally.
• 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.

Locations

Country	Name	City	State
Egypt	Ahmed Abass	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	postpartum hemorrhage	will be defined by postpartum blood loss of 1000cc	first 24 hours after delivery
Secondary	postoperative pain	pain scale from 0 to 10 to assess postoperative pain after delivery	2 hours after delivery
Secondary	postoperative pain	pain scale from 0 to 10 to assess postoperative pain at hours 2 after delivery	6 hours after delivery
Secondary	postoperative pain	pain scale from 0 to 10 to assess postoperative pain at hours 2 after delivery	12 hours after delivery
Secondary	postoperative pain	pain scale from 0 to 10 to assess postoperative pain at hours 2 after delivery	24 hours after delivery