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

Not Applicable

• Conditions: Suture, Complication; Vaginal Delivery; Tear; Cervix; Hematoma; Ecchymosis
• Interventions: Procedure: The Mostafa Maged four-stitch technique fore closure of the episiotomy; Procedure: patients of controlled group with routine closure of episiotomy

• Registration Number: NCT05247073
• Lead Sponsor: Fayoum University

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).

Study Timeline

• Study First Submitted: 2022-02-09
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-18
• Status Verified: 2022-03
• Study Start: 2022-03
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-03-29
• Primary Completion: 2022-04
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients of study group with Mostafa Maged technique for closure of the episiotomy	The Mostafa Maged four-stitch technique fore 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.
Patients of controlled group with routine closure of the episiotomy	patients of controlled group with routine closure of 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.

Primary Outcome Measures

Name	Time	Method
No edema at the site of episiotomy	4 weeks after delivery	Swelling or ecchymosis and edema at the edges of episiotomy
No infection at the episiotomy	4 weeks after delivery	Redness,hotness and bad odour of vaginal discharge
Heamostasis of the episiotomy	4 weeks after delivery	Bleeding from the epistiomy or heamatoma at the epistomy

Secondary Outcome Measures

Name	Time	Method
Sexual dysfunction (pain during sexual intercourse)	4 weeks after delivery	Pain during sexual intercourse
Anorectal dysfunction	4 weeks after delivery	Inability to control passage of stool or flatus or both