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

NCT05247073 | Unknown

• 1 other identifier: R 206
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Primigravida,; Episiotomy,; Childbirth,; Mostafa Maged; ecchymosis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Sexual dysfunction (pain during sexual intercourse)

  4 weeks after delivery

• Anorectal dysfunction

  4 weeks after delivery

Study Arms (2)

Patients of controlled group with routine closure of the episiotomy

OTHER

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

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

ACTIVE COMPARATOR

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

Interventions

patients of controlled group with routine closure of episiotomy 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 controlled group with routine closure of the episiotomy

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

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

Eligibility Criteria

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

You may qualify if:

• Primigravida patients having episiotomies or tears in the vagina
• Age between 18 to 40 years old

You may not qualify if:

• Smokers
• Diabetics
• Morbidly obese patients
• Chronic diseases such as renal diseases

Sponsors & Collaborators

• Fayoum University: lead

MeSH Terms

Conditions

Lacerations; Hematoma; Ecchymosis

Condition Hierarchy (Ancestors)

Wounds and Injuries; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Skin Manifestations; Signs and Symptoms

Study Officials

• Laila E Abdelfattah, Ass. prof

  Associated professor of obestatrics and gynecology Faculty of medicine Fayoume university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

rehab A aboshama, lecturer

CONTACT

01156608221; ras07@fayoum.edu.eg

Mostafa M Ali, resident

CONTACT

01093028005; supermostafa200@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of obstetrics and gynecology Faculty of medicine

Model Details: 25 Patients of controlled group with routine closure of the episiotomy 25 Patients of study group with Mostafa Maged technique for closure of the episiotomy

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 18, 2022
• Study Start: March 1, 2022
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share