Simple Continuous, Subcuticular and Interrupted Skin Sutu... | NCT03611452

Studies
Simple Continuous, Subcuticular and Interrupted Skin Suturing of Episiotomy and 2nd-degree Perineal Tears

NCT03611452

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Aug 2, 2018Actual

Enrollment

138Estimated

Phase

Not Applicable

Conditions

Episiotomy Wound

Interventions

Episiotomy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2018Estimated

Primary Completion Date

Jan 2019Estimated

Completion Date

Mar 2019Estimated

First Submitted Date

Jul 25, 2018

First Submission Date that Met QC Criteria

Aug 1, 2018

First Posted Date

Aug 2, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2018

Last Update Posted Date

Aug 2, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Millions of women worldwide undergo perineal suturing after childbirth and the type of repair may have an impact on pain and healing.

The skin as a barrier between the internal structures and the external environment is exceptionally susceptible to injury, either through accidental injury or planned surgical incision. Today, as surgery increases in complexity, and the heightened public awareness of scar cosmesis and skin healing need to be optimized to ensure the overall success of the surgical procedure

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

138Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Simple continuous	Experimental	the sutures will be taken continuously by simple method	Procedure: Episiotomy
subcuticular	Active Comparator	the sutures will be taken subcuticular	Procedure: Episiotomy
interrupted	Active Comparator	the sutures will be taken interrupted method	Procedure: Episiotomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Episiotomy	Procedure	repair of perineal muscles and skin	Simple continuous interrupted subcuticular

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the mean score of Perineal pain during vaginal suturing	assessment through visual analog scale score from 0 - 10 at every step of repair	10 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Normal vaginal delivery.
At term (37 40 weeks ).
Live baby.
Vertex presentation

Exclusion Criteria:

Third and fourth degree perineal tear.
Instrumental vaginal delivery.
Previous perineal surgery.
Anaemia with hemoglobin level < 9 g/dl.
Diabetes mellitus.
Coagulation abnormalities.
Postpartum hemorrhage.
Delivery conducted outside Woman HealthHospital.
Breech delivery.
Body mass index >35 kg/m2.
Local infectious lesions.
Anal fissures or hemorrhoid.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004841	Episiotomy

Ancestor Terms

ID	Term
D036861	Delivery, Obstetric
D013513	Obstetric Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided