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

Hematoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05247073
• Other study ID #: R 206
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2022
• Est. completion date: April 2022

Study information

• Verified date: March 2022
• Source: Fayoum University
• Contact: rehab A aboshama, lecturer
• Phone: 01156608221
• Email: ras07[@]fayoum.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Ecchymosis
• Hematoma
• Suture, Complication
• Vaginal Delivery

Intervention

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).
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fayoum University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heamostasis of the episiotomy	Bleeding from the epistiomy or heamatoma at the epistomy	4 weeks after delivery
Primary	No edema at the site of episiotomy	Swelling or ecchymosis and edema at the edges of episiotomy	4 weeks after delivery
Primary	No infection at the episiotomy	Redness,hotness and bad odour of vaginal discharge	4 weeks after delivery
Secondary	Sexual dysfunction (pain during sexual intercourse)	Pain during sexual intercourse	4 weeks after delivery
Secondary	Anorectal dysfunction	Inability to control passage of stool or flatus or both	4 weeks after delivery