Repair of Lateral And Mediolateral Episiotomy

NCT03486132 | Unknown DMC

• 1 other identifier: EPI
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Episiotomy Wound

Outcome Measures

Primary Outcomes (1)

• postoperative pain

  using visual analogue scale

  6 hours

Secondary Outcomes (5)

• Postoperative pain two monthes after delivery.

  TWO MONTHS

• Time taken in repair (min)

  1 hour

• Number of suture ampoules used.

  1 hour

• Dyspareunia

  two months

• Early complication of episiotomy eg; anal spincter injury, rectal mucosal injury, bleeding or heamatoma formation.

  1 hour

Study Arms (4)

interrupted repair of mediolateral episiotomy

OTHER

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

Procedure: repair of episiotomy

continous repair of mediolateral episiotomy

OTHER

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

Procedure: repair of episiotomy

interrupted repair of lateral episiotomy

OTHER

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

Procedure: repair of episiotomy

continuous repair of lateral episiotomy

OTHER

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

Procedure: repair of episiotomy

Interventions

repair of episiotomy PROCEDURE

Different techniques for repair of episiotomy incsicion

continous repair of mediolateral episiotomy; continuous repair of lateral episiotomy; interrupted repair of lateral episiotomy; interrupted repair of mediolateral episiotomy

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Primipara women.
• Fullterm pregnancy.
• Lateral or mediolateral episiotomy done in selective rather than liberal episiotomy.

You may not qualify if:

• Risk factor of trauma eg; macrosomia, congenital fetal malformations as (exophthalmous major, hydrocephalus, spinal cord teratoma….etc.
• Instrumental delivery.
• Primipara refuses to be in the study.
• Other techniques of episiotomy.
• Preterm onset of labour.
• Indication for CS eg; CPD, malposition and malpresentation, fetal distress….etc.
• Use of epidural analgesics.
• Factors affecting wound healing eg;DM, corticosteroid therapy, chronic debilitating diseases…etc.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain SHams Maternity Hospital

Cairo, 002, Egypt

RECRUITING

Central Study Contacts

Mohamed Samy, MD

CONTACT

01001947488; mohammedsamy8132@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Mohamed Samy

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: April 3, 2018
• Study Start: July 15, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: April 3, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)