An interventional study of patients of controlled group with routine closure of episiotomy and The Mostafa Maged four-stitch technique fore closure of the episiotomy in Vaginal Delivery, Suture, Complication and Tear; Cervix, sponsored by Fayoum University. Status unknown. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2022-03-29.
Sponsored by Fayoum University · Not applicable, Interventional, and Prevention
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.
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).
174 studies on the registry are indexed under Lacerations; 43 are open to participants now.
This study's planned enrollment of 50 is below the median of 65 across 128 interventional studies indexed under Lacerations.
Browse Lacerations studies →Fayoum University is the lead sponsor of 148 studies on the registry; 44 are open to participants now.
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Exclusion Criteria:
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
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
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).
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.
Heamostasis of the episiotomy
Bleeding from the epistiomy or heamatoma at the epistomy
Time frame: 4 weeks after delivery
No edema at the site of episiotomy
Swelling or ecchymosis and edema at the edges of episiotomy
Time frame: 4 weeks after delivery
No infection at the episiotomy
Redness,hotness and bad odour of vaginal discharge
Time frame: 4 weeks after delivery
Sexual dysfunction (pain during sexual intercourse)
Pain during sexual intercourse
Time frame: 4 weeks after delivery
Anorectal dysfunction
Inability to control passage of stool or flatus or both
Time frame: 4 weeks after delivery
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Mar 2022; primary completion for Apr 2022, 1 month later.
Of 46 non-industry interventional studies with no phase under Lacerations, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 72. This study's planned 1 month is below that.
Counting every sponsor, half of 50 studies reached it within 19 months; a quarter within 12 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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