Repair of Lateral And Mediolateral Episiotomy

NCT ID: NCT03486132

Last Updated: 2018-04-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-15
• Study Completion Date: 2018-05-31

Brief Summary

Episiotomy is an incision in the perineum carried out during the second stage of labour to facilitate the birth of an infant. It is an important surgical procedure with physiological, psychological and socio-economic effects on women. Therefore, not only the decision to carry out an episiotomy but also how it is performed and the quality of aftercare are important The two most often performed are the lateral and median episiotomy, as well as mediolateral episiotomy.

Two common methods of repair of episiotomy include continuous and interrupted methods This study aims to compare between postoperative pain following repair of episiotomy by continuous or interrupted suturing.

Detailed Description

Aim of the work:

This study aims to compare between postoperative pain following repair of episiotomy by continuous or interrupted suturing.

Study population:

All primipara full term women with episiotomy done in a selective rather than liberal use.

E- Patients in the study will be randomized into one of two groups either those who have:

1. Interrupted technique of episiotomy repair or

2. Continuous knotless suturing technique and each of the two groups will be subdivided into either medio-lateral or lateral episiotomy.

The Episiotomy in group A will be done using the interrupted suture (IT) which involves placing three layers of sutures: a continuous non-locking stitch to close the vaginal epithelium. commencing above the apex of the wound and finishing at the level of the fourchette; three or four interrupted sutures to reapproximate the deep and superficial perineal muscles; and interrupted transcutaneous technique to close the skin.

The Episiotomy in group B will be done using the continuous knotless suturing technique (CKT) which involves placing the first stitch above the apex of vaginal trauma to secure any bleeding points that might not be visible. Vaginal wound, perineal muscles (deep and superficial), and skin are reapproximated with a loose, continuous, non-locking technique. The skin sutures will be placed closely fairly deeply in the subcutaneous tissue, reversing back and finishing with a terminal knot placed in the vagina beyond the hymeneal remnants.

And subgroups subjected to Mediolateral episiotomy:it is defined as an incision beginning in the midline and directed laterally and downwards away from the rectum .The incision is usually about four centimeters long. In addition to the skin and subcutaneous tissues the bulbocavernosus, transverse perineal, and puborectalis muscles will be cut. And Lateral episiotomy; It begins in the vaginal introitus 1 or 2 cm lateral to the midline and is directe downwards towards the ischial tuberosity.

The standard suture material in the study will be EGYSORB (sterile coated synthetic polyglycolic acid absorbable braided suture) No 2/0, Manufacturer TAISIER-MED Company).

F- Written informed consent will be taken from all women participating in our search.

G- Data recording: age,weight,height,body mass index,type of anesthesia used,type of episiotomy,time taken,infection or gaped episiotomy, amount of bleeding, postpartum hemorrhage,amount of suture material used,amount of analgesia used, severity of pain detected by VAS.

H- all patient will be given oral nonnarcotic analgesics (NSAIDs eg; ibuprofen 600 mg every eight hours for three days , if NSAIDs is contraindicated acetaminophen/ paracetamol 500 mg every eight hours for three days.

I- Antibiotic prophylaxis will be given as a single dose of a broad spectrum antibiotic (second generation cephalosporin or clindamycin if the patient is allergic to penicillin

Conditions

Episiotomy Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

interrupted repair of mediolateral episiotomy

using the interrupted suture (IT) which involves placing three layers of sutures: a continuous non-locking stitch to close the vaginal epithelium. commencing above the apex of the wound and finishing at the level of the fourchette; three or four interrupted sutures to reapproximate the deep and superficial perineal muscles; and interrupted transcutaneous technique to close the skin.

The standard suture material in the study will be EGYSORB (sterile coated synthetic polyglycolic acid absorbable braided suture) No 2/0 Mediolateral episiotomy:it is defined as an incision beginning in the midline and directed laterally and downwards away from the rectum .The incision is usually about four centimeters long. In addition to the skin and subcutaneous tissues the bulbocavernosus, transverse perineal, and puborectalis muscles will be cut

Group Type: OTHER

repair of episiotomy

Intervention Type: PROCEDURE

Different techniques for repair of episiotomy incsicion

continous repair of mediolateral episiotomy

continuous knotless suturing technique (CKT) which involves placing the first stitch above the apex of vaginal trauma to secure any bleeding points that might not be visible. Vaginal wound, perineal muscles (deep and superficial), and skin are reapproximated with a loose, continuous, non-locking technique. The skin sutures will be placed closely fairly deeply in the subcutaneous tissue, reversing back and finishing with a terminal knot placed in the vagina beyond the hymeneal remnants Mediolateral episiotomy:it is defined as an incision beginning in the midline and directed laterally and downwards away from the rectum .The incision is usually about four centimeters long. In addition to the skin and subcutaneous tissues the bulbocavernosus, transverse perineal, and puborectalis muscles will be cut The standard suture material in the study will be EGYSORB (sterile coated synthetic polyglycolic acid absorbable braided suture) No 2/0

Group Type: OTHER

repair of episiotomy

Intervention Type: PROCEDURE

Different techniques for repair of episiotomy incsicion

interrupted repair of lateral episiotomy

using the interrupted suture (IT) which involves placing three layers of sutures: a continuous non-locking stitch to close the vaginal epithelium. commencing above the apex of the wound and finishing at the level of the fourchette; three or four interrupted sutures to reapproximate the deep and superficial perineal muscles; and interrupted transcutaneous technique to close the skin.

The standard suture material in the study will be EGYSORB (sterile coated synthetic polyglycolic acid absorbable braided suture) No 2/0 And Lateral episiotomy; It begins in the vaginal introitus 1 or 2 cm lateral to the midline and is directe downwards towards the ischial tuberosity

Group Type: OTHER

repair of episiotomy

Intervention Type: PROCEDURE

Different techniques for repair of episiotomy incsicion

continuous repair of lateral episiotomy

continuous knotless suturing technique (CKT) which involves placing the first stitch above the apex of vaginal trauma to secure any bleeding points that might not be visible. Vaginal wound, perineal muscles (deep and superficial), and skin are reapproximated with a loose, continuous, non-locking technique. The skin sutures will be placed closely fairly deeply in the subcutaneous tissue, reversing back and finishing with a terminal knot placed in the vagina beyond the hymeneal remnants And Lateral episiotomy; It begins in the vaginal introitus 1 or 2 cm lateral to the midline and is directe downwards towards the ischial tuberosity The standard suture material in the study will be EGYSORB (sterile coated synthetic polyglycolic acid absorbable braided suture) No 2/0

Group Type: OTHER

repair of episiotomy

Intervention Type: PROCEDURE

Different techniques for repair of episiotomy incsicion

Interventions

repair of episiotomy

Different techniques for repair of episiotomy incsicion

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Primipara women.

2. Fullterm pregnancy.

3. Lateral or mediolateral episiotomy done in selective rather than liberal episiotomy.

Exclusion Criteria

1. Risk factor of trauma eg; macrosomia, congenital fetal malformations as (exophthalmous major, hydrocephalus, spinal cord teratoma….etc.

2. Instrumental delivery.

3. Primipara refuses to be in the study.

4. Other techniques of episiotomy.

5. Preterm onset of labour.

6. Indication for CS eg; CPD, malposition and malpresentation, fetal distress….etc.

7. Use of epidural analgesics.

8. Factors affecting wound healing eg;DM, corticosteroid therapy, chronic debilitating diseases…etc.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

mohammed mahmoud samy

Dr. Mohamed Samy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain SHams Maternity Hospital

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohamed Samy, MD

Role: CONTACT

mohammedsamy8132@gmail.com

01001947488

Facility Contacts

Mohamed Samy, MD

Role: primary

mohammedsamy8132@gmail.com

01001947488

Other Identifiers

EPI

Identifier Type: -

Identifier Source: org_study_id