Vaginal DeliveryNCT05247073
Mostafa Maged Four-stitch Technique in Closure the Episiotomy During Vaginal Delivery
A study testing The Mostafa Maged four-stitch technique fore closure of the episiotomy in people with Vaginal Delivery and Suture, Complication, run by Fayoum University.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Vaginal Delivery, Suture, Complication, Tear; Cervix
- What is being tested?
- The Mostafa Maged four-stitch technique fore closure of the episiotomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Primigravida patients having episiotomies or tears in the vagina
- Age between 18 to 40 years old
Who cannot join
- Smokers
- Diabetics
- Morbidly obese patients
- Chronic diseases such as renal diseases
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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).
- Conditions
- Vaginal Delivery, Suture, Complication, Tear; Cervix, Hematoma, Ecchymosis
- Being tested
- patients of controlled group with routine closure of episiotomy, The Mostafa Maged four-stitch technique fore closure of the episiotomy
- Keywords
- Primigravida,, Episiotomy,, Childbirth,, Mostafa Maged, ecchymosis
- Medical subject headings
- Lacerations, Hematoma, Ecchymosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients of controlled group with routine closure of episiotomyProcedure or surgery
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 episiotomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: The Mostafa Maged four-stitch technique fore closure of the episiotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heamostasis of the episiotomy
Bleeding from the epistiomy or heamatoma at the epistomy
Measured: 4 weeks after delivery
No edema at the site of episiotomy
Swelling or ecchymosis and edema at the edges of episiotomy
Measured: 4 weeks after delivery
No infection at the episiotomy
Redness,hotness and bad odour of vaginal discharge
Measured: 4 weeks after delivery
Secondary outcomes (2)
Sexual dysfunction (pain during sexual intercourse)
Pain during sexual intercourse
Measured: 4 weeks after delivery
Anorectal dysfunction
Inability to control passage of stool or flatus or both
Measured: 4 weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study startMar 2022 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal DeliveryStudies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rehab abdelhamid aboshama, Fayoum University
- Investigators
- Laila E Abdelfattah, Ass. prof, Principal investigator, Associated professor of obestatrics and gynecology Faculty of medicine Fayoume university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247073
- Sponsor's protocol ID
- R 206
- Status last verified
- Mar 2022
- First submitted
- 9 Feb 2022
- Last updated
- 29 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05247073
- Acronym / sponsor ID
- R 206
- Conditions
- Vaginal Delivery, Suture, Complication, Tear; Cervix, Hematoma, Ecchymosis
- Keywords
- Primigravida,, Episiotomy,, Childbirth,, Mostafa Maged, ecchymosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Patients of controlled group with routine closure of the episiotomy | Other | Procedure: patients of controlled group with routine closure of episiotomyThe 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. |
| Patients of study group with Mostafa Maged technique for closure of the episiotomy | Active comparator | Procedure: The Mostafa Maged four-stitch technique fore closure of the episiotomyThe 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Primigravida patients having episiotomies or tears in the vagina
- Age between 18 to 40 years old
Key exclusion criteria (4 listed)
- Smokers
- Diabetics
- Morbidly obese patients
- Chronic diseases such as renal diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patients of controlled group with routine closure of episiotomyPerineal 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). | Procedure or surgery | Patients of controlled group with routine closure of the episiotomy |
| The Mostafa Maged four-stitch technique fore closure of the episiotomyIdentification 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. | Procedure or surgery | Patients of study group with Mostafa Maged technique for closure of the episiotomy |
Primary outcome
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
2 secondary outcomes
Sexual dysfunction (pain during sexual intercourse)
Time frame: 4 weeks after delivery
Anorectal dysfunction
Time frame: 4 weeks after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laila E Abdelfattah, Ass. prof principal investigator
Associated professor of obestatrics and gynecology Faculty of medicine Fayoume university
Questions about this trial
What is this clinical trial studying?
A study testing The Mostafa Maged four-stitch technique fore closure of the episiotomy in people with Vaginal Delivery and Suture, Complication, run by Fayoum University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact rehab A aboshama, lecturer (01156608221, ras07@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heamostasis of the episiotomy (time frame: 4 weeks after delivery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.