Difference Between Monofilament Versus Multifilament Suture Material in Isthmocele Formation
Impact of Using Synthetic Absorbable Monofilament Versus Multifilament Suture Material for Uterine Closure on the Development of Uterine Isthmocele : A Rondamized Controlled Clinical Trial
1 other identifier
interventional
140
1 country
1
Brief 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 . 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2024
CompletedFirst Submitted
Initial submission to the registry
December 8, 2024
CompletedFirst Posted
Study publicly available on registry
December 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedDecember 19, 2024
December 1, 2024
1 year
December 8, 2024
December 17, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
The incidence of isthmocele by transvaginal ultrasound 6 months after delivery
Effect of using monofilament sutures on the development of uterine scar niche
6 months
Study Arms (2)
Monocryl arm
EXPERIMENTALVicryl arm
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- Age: 20-45 years old
- Singleton pregnancy.
- Gestational age between 37 completed weeks to 42 weeks.
- Patients undergoing elective primary caesarean section
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of medicine
Cairo, Abbasya, Egypt
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer
Study Record Dates
First Submitted
December 8, 2024
First Posted
December 19, 2024
Study Start
January 1, 2024
Primary Completion
January 1, 2025
Study Completion
March 1, 2025
Last Updated
December 19, 2024
Record last verified: 2024-12