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

Primary Purpose

Vaginal Delivery, Suture, Complication, Tear; Cervix

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
patients of controlled group with routine closure of episiotomy
The Mostafa Maged four-stitch technique fore closure of the episiotomy
Sponsored by
Fayoum University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vaginal Delivery focused on measuring Primigravida,, Episiotomy,, Childbirth,, Mostafa Maged, ecchymosis

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Active Comparator

    Arm Label

    Patients of controlled group with routine closure of the episiotomy

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

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Heamostasis of the episiotomy
    Bleeding from the epistiomy or heamatoma at the epistomy
    No edema at the site of episiotomy
    Swelling or ecchymosis and edema at the edges of episiotomy
    No infection at the episiotomy
    Redness,hotness and bad odour of vaginal discharge

    Secondary Outcome Measures

    Sexual dysfunction (pain during sexual intercourse)
    Pain during sexual intercourse
    Anorectal dysfunction
    Inability to control passage of stool or flatus or both

    Full Information

    First Posted
    February 9, 2022
    Last Updated
    March 28, 2022
    Sponsor
    Fayoum University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05247073
    Brief Title
    Mostafa Maged Four-stitch Technique in Closure the Episiotomy During Vaginal Delivery
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2022 (Anticipated)
    Primary Completion Date
    April 2022 (Anticipated)
    Study Completion Date
    April 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fayoum University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vaginal Delivery, Suture, Complication, Tear; Cervix, Hematoma, Ecchymosis
    Keywords
    Primigravida,, Episiotomy,, Childbirth,, Mostafa Maged, ecchymosis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients of controlled group with routine closure of the episiotomy
    Arm Type
    Other
    Arm Description
    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.
    Arm Title
    Patients of study group with Mostafa Maged technique for closure of the episiotomy
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    patients of controlled group with routine closure of episiotomy
    Intervention Description
    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).
    Intervention Type
    Procedure
    Intervention Name(s)
    The Mostafa Maged four-stitch technique fore closure of the episiotomy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Heamostasis of the episiotomy
    Description
    Bleeding from the epistiomy or heamatoma at the epistomy
    Time Frame
    4 weeks after delivery
    Title
    No edema at the site of episiotomy
    Description
    Swelling or ecchymosis and edema at the edges of episiotomy
    Time Frame
    4 weeks after delivery
    Title
    No infection at the episiotomy
    Description
    Redness,hotness and bad odour of vaginal discharge
    Time Frame
    4 weeks after delivery
    Secondary Outcome Measure Information:
    Title
    Sexual dysfunction (pain during sexual intercourse)
    Description
    Pain during sexual intercourse
    Time Frame
    4 weeks after delivery
    Title
    Anorectal dysfunction
    Description
    Inability to control passage of stool or flatus or both
    Time Frame
    4 weeks after delivery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Primigravida patients having episiotomies or tears in the vagina Age between 18 to 40 years old Exclusion Criteria: Smokers Diabetics Morbidly obese patients Chronic diseases such as renal diseases
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    rehab A aboshama, lecturer
    Phone
    01156608221
    Email
    ras07@fayoum.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mostafa M Ali, resident
    Phone
    01093028005
    Email
    supermostafa200@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Laila E Abdelfattah, Ass. prof
    Organizational Affiliation
    Associated professor of obestatrics and gynecology Faculty of medicine Fayoume university
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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