NCT02288013

Brief Summary

Comparative study of the surgical outcome of 2-layers closure technique of uterine incision in Cesarean section using bidirectional barbed suture (Stratafix) and conventional suture material (Vicryl) regarding the time of closure and the need of secondary additional suturing or tearing of uterine muscles during suturing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 11, 2014

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 27, 2016

Status Verified

January 1, 2016

Enrollment Period

1.2 years

First QC Date

November 5, 2014

Last Update Submit

January 26, 2016

Conditions

Cesarean Section

Keywords

Cesarean sectionuterine closure techniquematerials used

Outcome Measures

Primary Outcomes (1)

  • Time needed to close the uterine incision

    A model is set to evaluate success and failure according the ime needed to close the uterine incision if more or less than 6 minutes

    6 minutes

Secondary Outcomes (1)

  • blood loss during uterine closure

    intraoperative during uterine closure

Other Outcomes (1)

  • Duration of hospital stay

    Six weeks following the cesarean delivery (completion of the postpartum period)

Study Arms (2)

Stratafix Tissue control device

OTHER

Closure of Uterine incision at C section

Procedure: Closure of uterine incision at C section

Vicryl suture

OTHER

Closure of uterine incision at C section

Procedure: Closure of uterine incision at C section

Interventions

Closure of uterine incision at C sectionPROCEDURE

Closure of uterine incision at Cesarean section

Stratafix Tissue control deviceVicryl suture

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All pregnant patients with an indication for delivery by C section

You may not qualify if:

  • Patient refusing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Cairo University

Cairo, Cairo Governorate, 11559, Egypt

Location

Study Officials

  • Mohamed Z Ahmed, MD PhD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Obstetrics and Gynecology Cairo University

Study Record Dates

First Submitted

November 5, 2014

First Posted

November 11, 2014

Study Start

October 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 27, 2016

Record last verified: 2016-01

Locations

EG(1)