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

Primary Purpose

Cesarean Section Scar

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Cesarean section incision closure using barbed sutures

Cesarean section incision closure using conventional sutures

About this trial

This is an interventional diagnostic trial for Cesarean Section Scar focused on measuring Cesarean section scar, Barbed suture, Conventional suture

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Primigravida patients undergoing transverse lower segment cesarean section

Exclusion Criteria:

Previous laparotomies
Postoperative fever
Patients with preterm pregnancies or in labor

Sites / Locations

Cairo university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cesarean section incision closure using barbed sutures

Cesarean section incision closure using conventional sutures

Arm Description

Cesarean section incision is closed using barbed sutures

Cesarean section incision is closed using conventional sutures

Outcomes

Primary Outcome Measures

Residual myometrial thickness

Thickness of myometrium under the niche

Secondary Outcome Measures

Scar depth

Full Information

NCT ID

NCT03182010

First Posted

June 7, 2017

Last Updated

June 12, 2017

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03182010

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Unknown status

Study Start Date

August 2017 (Anticipated)

Primary Completion Date

August 2020 (Anticipated)

Study Completion Date

August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cesarean Section Scar

Keywords

Cesarean section scar, Barbed suture, Conventional suture

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cesarean section incision closure using barbed sutures

Arm Type

Experimental

Arm Description

Cesarean section incision is closed using barbed sutures

Arm Title

Cesarean section incision closure using conventional sutures

Arm Type

Active Comparator

Arm Description

Cesarean section incision is closed using conventional sutures

Intervention Type

Device

Intervention Name(s)

Cesarean section incision closure using barbed sutures

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Cesarean section incision closure using conventional sutures

Intervention Description

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.

Primary Outcome Measure Information:

Title

Residual myometrial thickness

Description

Thickness of myometrium under the niche

Time Frame

Six months after cesarean section

Secondary Outcome Measure Information:

Title

Scar depth

Time Frame

Six months after cesarean section

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Primigravida patients undergoing transverse lower segment cesarean section Exclusion Criteria: Previous laparotomies Postoperative fever Patients with preterm pregnancies or in labor

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Usama M Fouda, Prof.

Phone

01095401375

umfrfouda@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Usama M Fouda, Prof.

Organizational Affiliation

Cairo University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Mohamed Zayed, Prof.

Organizational Affiliation

Cairo University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cairo university

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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