Ultrasound Evaluation of Cesarean Scar After Uterotomy Closure With Barbed and Conventional Sutures

Ultrasound Evaluation of Cesarean Scar After Uterotomy Closure With Barbed and Conventional Sutures ; a Randomized Controlled Study

The aim of this randomized control trial is to compare the residual myometrial thickness and the depth of cesarean section scar defect after uterine incision closure with barbed or conventional sutures.

Study Overview

• Status: Unknown
• Conditions: Cesarean Section Scar
• Intervention / Treatment: Device: Cesarean section incision closure using barbed sutures; Device: Cesarean section incision closure using conventional sutures

Detailed Description

The aim of this randomized control trial is to compare the residual myometrial thickness and the depth of cesarean section scar defect after uterine incision closure with barbed or conventional sutures. Primigravida patients undergoing transverse lower segment cesarean section will be included in the study.Cesarean section incision will be closed with double layers of continuous barbed or conventional sutures. Ultrasound examination will be performed 6 months after the operation to measure the residual myometrial thickness and the scar depth.

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Primigravida patients undergoing transverse lower segment cesarean section

Exclusion Criteria:

• Previous laparotomies
• Postoperative fever
• Patients with preterm pregnancies or in labor

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cesarean section incision closure using barbed sutures; Cesarean section incision is closed using barbed sutures	Device: Cesarean section incision closure using barbed sutures; Cesarean section incision will be closed using a 24-cm × 24-cm 0 polydioxanone double-armed suture on a 26-mm half-circle reverse cutting needle( STRATAFIX™ Spiral PDO Knotless Tissue Control Device, Ethicon Inc , Somerville, NJ, USA ).Ultrasound examination will be performed 6 months after the operation to measure the residual myometrial thickness and the scar depth.
Active Comparator: Cesarean section incision closure using conventional sutures; Cesarean section incision is closed using conventional sutures	Device: Cesarean section incision closure using conventional sutures; Cesarean section incision will be closed using 1-0 polyglactin 910 suture(VICRYL™.; Ethicon Inc, Sommerville, NJ) .Ultrasound examination will be performed 6 months after the operation to measure the residual myometrial thickness and the scar depth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual myometrial thickness	Thickness of myometrium under the niche	Six months after cesarean section

Secondary Outcome Measures

Outcome Measure	Time Frame
Scar depth	Six months after cesarean section

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Usama M Fouda, Prof., Cairo University; Principal Investigator: Mohamed Zayed, Prof., Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2017
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: June 7, 2017
• First Submitted That Met QC Criteria: June 7, 2017
• First Posted (Actual): June 9, 2017

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: June 12, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Cesarean section scar, Barbed suture, Conventional suture
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix
• Other Study ID Numbers: Barbed sutures/Cesarean scar

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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