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

NCT ID: NCT03611452

Last Updated: 2018-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-31

Study Completion Date

2019-03-31

Brief Summary

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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

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Conditions

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Episiotomy Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Simple continuous

the sutures will be taken continuously by simple method

Group Type EXPERIMENTAL

Episiotomy

Intervention Type PROCEDURE

repair of perineal muscles and skin

subcuticular

the sutures will be taken subcuticular

Group Type ACTIVE_COMPARATOR

Episiotomy

Intervention Type PROCEDURE

repair of perineal muscles and skin

interrupted

the sutures will be taken interrupted method

Group Type ACTIVE_COMPARATOR

Episiotomy

Intervention Type PROCEDURE

repair of perineal muscles and skin

Interventions

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Episiotomy

repair of perineal muscles and skin

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Abbas

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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SCIE

Identifier Type: -

Identifier Source: org_study_id

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