Mostafa Maged Four-stitch Technique in Closure the Episiotomy During Vaginal Delivery

NCT ID: NCT05247073

Last Updated: 2022-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-31
• Study Completion Date: 2022-04-30

Brief Summary

Most primigravida is confronted with episiotomy during childbirth to prevent the perineal and vaginal lacerations which could be performed at birth. There are many types of episiotomy which are median, mediolateral, and J-shaped episiotomy.

Prevention of the formation of the dead space during the repair of episiotomy so avoiding hematoma formation in the episiotomy area after child-birth.

The Mostafa Maged four-stitch technique uses absorbable vicryl threads with round needles 75 mm.

Detailed Description

Methodology: This technique will be applied to all women with episiotomy at the time of delivery or having tears in the perineum or the vagina. The technique uses absorbable vicryl threads with round needles 75 mm long. The technique includes the vaginal epithelium and the deep muscle layer together continuously at the same sutures. Assessment of the perineal area in the next twenty-four hours till discharge looking for (edema - hematoma - septic wound - continence - ecchymosis - dyspareunia).

Conditions

Vaginal Delivery; Suture, Complication; Tear; Cervix; Hematoma; Ecchymosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Patients of controlled group with routine closure of the episiotomy

The vagina will be stitched using a continuous locking stitch and the perineal muscles and skin are repaired using approximately three or four individual stitches, each needing to be knotted separately to prevent them from dislodging.

Group Type: OTHER

patients of controlled group with routine closure of episiotomy

Intervention Type: PROCEDURE

Perineal trauma is traditionally repaired in three stages: a continuous locking stitch is inserted to close the vaginal trauma, commencing at the apex of the wound and finishing at the level of the fourchette with a loop knot. The perineal muscles are then re-approximated with three or four interrupted sutures and finally, the perineal skin is closed by inserting continuous subcutaneous or interrupted transcutaneous stitches.

The skin is then closed with inverted interrupted stitches placed in the subcutaneous tissue a few millimeters under the perineal skin edges (not transcutaneously).

Patients of study group with Mostafa Maged technique for closure of the episiotomy

The vagina will be stitched with the Mostafa Maged technique, The Mostafa Maged four-stitch technique uses absorbable vicryl threads with round needles 75 mm. The technique will prevent dead space formation, Good and tight hemostasis of the episiotomy strong approximation of the two edges of the episiotomy.

Group Type: ACTIVE_COMPARATOR

The Mostafa Maged four-stitch technique fore closure of the episiotomy

Intervention Type: PROCEDURE

Identification of the apex of the episiotomy, then a simple suture is taken (0.5 cm) behind the apex of the episiotomy. First, the needle is inserted at the vaginal mucosa of the right edge of the episiotomy then extract the needle.

The second stitch is inserted on the deep muscle layer of the same side (Right side) of the episiotomy cutting edge then extracting the needle.

Then, insert the needle again on the left side of the episiotomy incision in the deep muscle layer on the left side of the episiotomy incision directing the tip of the needle upwards parallel to the second stitch taken.

The fourth step is inserting the needle in the vaginal mucosa of the left side parallel to the first stitch. Continue suturing the episiotomy incision continuously in the same way till reaching the remnant of the hymen.

Then suture the superficial perineal muscle in a continuous manner and the skin in a subcuticular manner as well.

Interventions

patients of controlled group with routine closure of episiotomy

Perineal trauma is traditionally repaired in three stages: a continuous locking stitch is inserted to close the vaginal trauma, commencing at the apex of the wound and finishing at the level of the fourchette with a loop knot. The perineal muscles are then re-approximated with three or four interrupted sutures and finally, the perineal skin is closed by inserting continuous subcutaneous or interrupted transcutaneous stitches.

The skin is then closed with inverted interrupted stitches placed in the subcutaneous tissue a few millimeters under the perineal skin edges (not transcutaneously).

Intervention Type: PROCEDURE

The Mostafa Maged four-stitch technique fore closure of the episiotomy

Identification of the apex of the episiotomy, then a simple suture is taken (0.5 cm) behind the apex of the episiotomy. First, the needle is inserted at the vaginal mucosa of the right edge of the episiotomy then extract the needle.

The second stitch is inserted on the deep muscle layer of the same side (Right side) of the episiotomy cutting edge then extracting the needle.

Then, insert the needle again on the left side of the episiotomy incision in the deep muscle layer on the left side of the episiotomy incision directing the tip of the needle upwards parallel to the second stitch taken.

The fourth step is inserting the needle in the vaginal mucosa of the left side parallel to the first stitch. Continue suturing the episiotomy incision continuously in the same way till reaching the remnant of the hymen.

Then suture the superficial perineal muscle in a continuous manner and the skin in a subcuticular manner as well.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Primigravida patients having episiotomies or tears in the vagina

2. Age between 18 to 40 years old

Exclusion Criteria

1. Smokers

2. Diabetics

3. Morbidly obese patients

4. Chronic diseases such as renal diseases

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fayoum University

OTHER

Sponsor Role: lead

Responsible Party

rehab abdelhamid aboshama

lecturer of obstetrics and gynecology Faculty of medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laila E Abdelfattah, Ass. prof

Role: PRINCIPAL_INVESTIGATOR

Associated professor of obestatrics and gynecology Faculty of medicine Fayoume university

Central Contacts

rehab A aboshama, lecturer

Role: CONTACT

ras07@fayoum.edu.eg

01156608221

Mostafa M Ali, resident

Role: CONTACT

supermostafa200@yahoo.com

01093028005

Other Identifiers

R 206

Identifier Type: -

Identifier Source: org_study_id