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

Sponsor

Cairo University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03182010

Collaborator

(none)

110

Enrollment

Location

Arms

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Cesarean Section Scar	Device: Cesarean section incision closure using barbed sutures Device: Cesarean section incision closure using conventional sutures	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2017

Anticipated Primary Completion Date :

Aug 1, 2020

Anticipated Study Completion Date :

Aug 1, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Residual myometrial thickness [Six months after cesarean section]
Thickness of myometrium under the niche

Secondary Outcome Measures

Scar depth [Six months after cesarean section]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo university	Cairo		Egypt

Sponsors and Collaborators

Cairo University

Investigators

Study Chair: Usama M Fouda, Prof., Cairo University
Principal Investigator: Mohamed Zayed, Prof., Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Usama M Fouda, Prof., Cairo University

ClinicalTrials.gov Identifier:

NCT03182010

Other Study ID Numbers:

Barbed sutures/Cesarean scar

First Posted:

Jun 9, 2017

Last Update Posted:

Jun 14, 2017

Last Verified:

Jun 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Usama M Fouda, Prof., Cairo University

Cesarean section scar, Barbed suture, Conventional suture

Additional relevant MeSH terms:

Cicatrix

Study Results

No Results Posted as of Jun 14, 2017