Difference Between Monofilament Versus Multifilament Suture Material in Isthmocele Formation
NCT ID: NCT06741371
Last Updated: 2024-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
140 participants
INTERVENTIONAL
2024-01-01
2025-03-01
Brief Summary
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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
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Monocryl arm
Monocryl
Closure of the uterine scar by monofilament suture material
Vicryl arm
No interventions assigned to this group
Interventions
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Monocryl
Closure of the uterine scar by monofilament suture material
Eligibility Criteria
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Inclusion Criteria
* Singleton pregnancy.
* Gestational age between 37 completed weeks to 42 weeks.
* Patients undergoing elective primary caesarean section
Exclusion Criteria
* 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)
20 Years
45 Years
FEMALE
Yes
Sponsors
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Ain Shams Maternity Hospital
OTHER
Responsible Party
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Mohammed Essam ElDin Mohammed
Assistant lecturer
Locations
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Faculty of medicine
Cairo, Abbasya, Egypt
Countries
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Central Contacts
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Mohammed Hamed, Prof
Role: CONTACT
Phone: 01226067272
Provided Documents
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Document Type: Study Protocol and Informed Consent Form
Other Identifiers
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FMASU MD333/2023
Identifier Type: -
Identifier Source: org_study_id