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

Cesarean Section Scar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03182010
• Other study ID #: Barbed sutures/Cesarean scar
• Status: Not yet recruiting
• Phase: N/A
• First received: June 7, 2017
• Last updated: June 12, 2017
• Start date: August 2017
• Est. completion date: August 2020

Study information

• Verified date: June 2017
• Source: Cairo University
• Contact: Usama M Fouda, Prof.
• Phone: 01095401375
• Email: umfrfouda[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Primigravida patients undergoing transverse lower segment cesarean section

Exclusion Criteria:

• Previous laparotomies

• Postoperative fever

• Patients with preterm pregnancies or in labor

Related Conditions & MeSH terms

• Cesarean Section Scar

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual myometrial thickness	Thickness of myometrium under the niche	Six months after cesarean section
Secondary	Scar depth		Six months after cesarean section