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

• Sponsor: Ain Shams University (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT03224247
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 11
• Patients Per Site Per Month: 36.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cesarean Section Complications	Procedure: Transverse cutting; Procedure: vertical splitting	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Jan 1, 2021
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. postpartum hemorrhage [first 24 hours after delivery]

   will be defined by postpartum blood loss of 1000cc

4. postoperative pain [2 hours after delivery]

   pain scale from 0 to 10 to assess postoperative pain after delivery

5. postoperative pain [6 hours after delivery]

   pain scale from 0 to 10 to assess postoperative pain at hours 2 after delivery

6. postoperative pain [12 hours after delivery]

   pain scale from 0 to 10 to assess postoperative pain at hours 2 after delivery

7. postoperative pain [24 hours after delivery]

   pain scale from 0 to 10 to assess postoperative pain at hours 2 after delivery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmed Abass	Cairo		Egypt	11311

Sponsors and Collaborators

• Ain Shams University

Investigators

• Study Director: Waled Hitler, Prof, AinShams University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Abass, Lecturer, Ain Shams University
• ClinicalTrials.gov Identifier: NCT03224247
• Other Study ID Numbers: Vertical splitting in CS
• First Posted: Jul 21, 2017
• Last Update Posted: Jan 20, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ahmed Abass, Lecturer, Ain Shams University: vertical splitting; Cesarean Section Complications; uterine vessels; injury

Study Results

No Results Posted as of Jan 20, 2021