Uterine ScarNCT06741371
Difference Between Monofilament Versus Multifilament Suture Material in Isthmocele Formation
A study testing Monocryl in people with Uterine Scar, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
This thesis conducts the effect of using different suture materials on the development of uterine scar niche after cesarean section. The difference between monofilament and multifilament sutures and the special properties of each one . Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Scar
- What is being tested?
- Monocryl
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 20-45 years old
- Singleton pregnancy.
- Gestational age between 37 completed weeks to 42 weeks.
- Patients undergoing elective primary caesarean section
Who cannot join
- History of uterine surgery (e.g. hysterotomy, myomectomy, perforation, caesarean section). (to be able to differentiate between the recent CS scar and the old scar)
- Abnormal placental invasion (placenta previa and accrete ) ( more liable to undergo Cesarean hysterectomy)
- Uterine anomalies (e.g., septum, Mullerian anomalies or fibroids). (may be localized at the suture line and therefore affect the scar)
- Drugs intake that affects bleeding or tissue healing e.g., anti-coagulants, immunosuppressive drugs and chronic use of steroids (more than 14 days pre-operative)
- Any medical Co-morbidity (diabetes mellitus, Hypertension and Thyroid abnormalities) (more liable to affect the healing)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mohammed Hamed, Prof contact
About this study
Official title: Impact of Using Synthetic Absorbable Monofilament Versus Multifilament Suture Material for Uterine Closure on the Development of Uterine Isthmocele : A Rondamized Controlled Clinical Trial
This thesis conducts the effect of using different suture materials on the development of uterine scar niche after cesarean section.
The difference between monofilament and multifilament sutures and the special properties of each one .
The primary outcome of the study is to know which material conducts more scar niche formation .
Secondary outcomes are the extent of blood loss , the need of extra hemostatic sutures
- Conditions
- Uterine Scar
- Being tested
- Monocryl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MonocrylProcedure or surgery
Closure of the uterine scar by monofilament suture material
| Study group | Role | What they receive |
|---|---|---|
| Monocryl arm | Experimental | Not described Receives: Procedure: Monocryl |
| Vicryl arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of isthmocele by transvaginal ultrasound 6 months after delivery
Effect of using monofilament sutures on the development of uterine scar niche
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start1 Jan 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine ScarStudies of the same condition, open and under way.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Essam ElDin Mohammed, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741371
- Sponsor's protocol ID
- FMASU MD333/2023
- Status last verified
- Dec 2024
- First submitted
- 8 Dec 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Using Synthetic Absorbable Monofilament Versus Multifilament Suture Material for Uterine Closure on the Development of Uterine Isthmocele : A Rondamized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06741371
- Acronym / sponsor ID
- FMASU MD333/2023
- Conditions
- Uterine Scar
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 19 Dec 2024 (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.
This thesis conducts the effect of using different suture materials on the development of uterine scar niche after cesarean section.
The difference between monofilament and multifilament sutures and the special properties of each one .
The primary outcome of the study is to know which material conducts more scar niche formation .
Secondary outcomes are the extent of blood loss , the need of extra hemostatic sutures
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monocryl arm | Experimental | Procedure: Monocryl |
| Vicryl arm | No intervention | – |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 20-45 years old
Key exclusion criteria (5 listed)
- History of uterine surgery (e.g. hysterotomy, myomectomy, perforation, caesarean section). (to be able to differentiate between the recent CS scar and the old scar)
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 |
|---|---|---|
| MonocrylClosure of the uterine scar by monofilament suture material | Procedure or surgery | Monocryl arm |
Primary outcome
The incidence of isthmocele by transvaginal ultrasound 6 months after delivery
Time frame: 6 months
Effect of using monofilament sutures on the development of uterine scar niche
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Mohammed Hamed, Prof contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monocryl in people with Uterine Scar, run by Ain Shams Maternity Hospital at 1 site in Egypt.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Hamed, Prof (01226067272 ext. 202), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of isthmocele by transvaginal ultrasound 6 months after delivery (time frame: 6 months). 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 19 Dec 2024.