This clinical trial study was conducted to 50 pregnant women, aged 18 years or more and who are suitable for normal vaginal delivery, they were enrolled to this study after taking an ethical committee approval in Egypt. A detailed history was taken from all participants, and general examination to exclude the presence of any disorders. Obstetric examinations were performed. Verbal and written consents from all patients are obtained to be recruited in this study.
All relevant information, like the purpose and methodology of the experiment, was explained to study participants beforehand, and informed consent was obtained. All procedures of the present study were conducted in compliance with the Helsinki declaration for research on human beings. The study was approved by the research ethics committee.
Clinical trial number (ClinicalTrials.gov Identifier) is NCT05247073
Active Comparator of this study (Procedure of Mostafa Maged technique: 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 of Mostafa Maged technique:

Mostafa Maged four-stitch technique for 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 (epithelium) of the right edge of the episiotomy then extracts the needle.

The second stitch is inserted on the 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 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 (epithelium) 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 (fourchette). Then, I make a loop knot at the fourchette. Then, suturing the superficial perineal muscle in a continuous manner and the skin in a subcuticular manner as well. Mostafa Maged technique is illustrated in a model of uterus in Figure (2).

There is a case series of this (Mostafa Maged technique) recently published to reveal this technique (13 ).
Patients of controlled group: 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 with routine traditional closure of the episiotomy): 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 trans-cutaneously).
While primigravida patients having episiotomies or tears in the vagina and age between 18 to 40 years old were included in the study; whereas, smokers, diabetics, morbidly obese patients, cases with chronic diseases such as renal diseases and cases with 3rd and 4th perineal tears were excluded.
Primary Outcome Measures:Heamostasis of the episiotomy [Time Frame: 4 weeks after delivery] (Bleeding from the epistiomy or heamatoma at the epistomy).
No edema at the site of episiotomy [Time Frame: 4 weeks after delivery] (Swelling or ecchymosis and edema at the edges of episiotomy).
No infection at the episiotomy [Time Frame: 4 weeks after delivery] (Redness, hotness and bad odour of vaginal discharge)
Secondary Outcome Measures:Sexual dysfunction (pain during sexual intercourse) [Time Frame: 4 weeks after delivery] (Pain during sexual intercourse)
Anorectal dysfunction [Time Frame: 4 weeks after delivery] (Inability to control passage of stool or flatus or both).
Statistical analysis: Data collection and coding were performed to enable data manipulation as well as double entered into Microsoft Access, and the analysis was done utilizing version 22 of the Statistical Package of Social Science (SPSS) (SPSS Inc., Chicago, IL, USA). In addition, a simple descriptive analysis was performed using percentages and numbers of qualitative data, standard deviations for the dispersion of quantitative parametric data, as well as arithmetic means as central tendency measurement.
For quantitative data: Independent samples t-test was utilized for comparing quantitative measures between two independent groups.
For qualitative data: The Chi-square test was utilized for comparing two of more than two qualitative groups. The p-value< 0.05 was considered statistically significant.
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