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

A Randomized Controlled Trial to Evaluate the Mostafa Maged Four-stitch Technique in Comparison With the Regular Method in Closure of the Episiotomy During Vaginal Delivery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hematoma; Suture, Complication; Ecchymosis; Vaginal Delivery; Tear; Cervix
• Intervention / Treatment: Procedure: patients of controlled group with routine closure of episiotomy; Procedure: The Mostafa Maged four-stitch technique fore closure of the episiotomy

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: rehab A aboshama, lecturer; Phone Number: 01156608221; Email: ras07@fayoum.edu.eg
• Study Contact Backup: Name: Mostafa M Ali, resident; Phone Number: 01093028005; Email: supermostafa200@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Procedure: 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).
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fayoum University
• Investigators: Principal Investigator: Laila E Abdelfattah, Ass. prof, Associated professor of obestatrics and gynecology Faculty of medicine Fayoume university

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: ecchymosis; Primigravida,; Episiotomy,; Childbirth,; Mostafa Maged
• Additional Relevant MeSH Terms: Pathologic Processes; Hematologic Diseases; Hemorrhage; Blood Coagulation Disorders; Skin Manifestations; Hematoma; Ecchymosis
• Other Study ID Numbers: R 206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No