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Clinical Trials/NCT03183362
NCT03183362UnknownNot Applicable

Comparison of Barbed and Conventional Sutures in Adhesion Formation Following Cesarean Section; a Randomized Controlled Study

Cairo University1 site in 1 country110 target enrollmentStarted: August 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
110
Locations
1
Primary Endpoint
Adhesions formation rate

Study Overview

Brief Summary

The aim of this randomized controlled trial is to determine whether the use of barbed sutures to close uterine incision at cesarean section is associated with more postoperative adhesions compared with conventional sutures or not.

Detailed Description

The aim of this randomized controlled trial is to determine whether the use of barbed sutures to close uterine incision at cesarean section is associated with an increase in the rate of postoperative adhesions compared with conventional sutures or not. 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.Patients who will return for a repeat caesarean (elective or emergency) will be evaluated intraoperatively for the presence of adhesions between various pelvic structures.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Primigravida patients undergoing transverse lower segment cesarean section

Exclusion Criteria

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

Outcomes

Primary Outcomes

Adhesions formation rate

Time Frame: Through study completion, an average of 3 year

Patients who will return for a repeat caesarean (elective or emergency) will be evaluated intraoperatively for the presence of adhesions between various pelvic structures.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Usama M Fouda

Prof.

Cairo University

Study Sites (1)

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