Difference Between Monofilament Versus Multifilament Suture Material in Isthmocele Formation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Monocryl.
- Who it may be relevant to
- Registry conditions: Uterine Scar. Basic parameters: 20 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
Interventions
- Procedure Monocryl
Closure of the uterine scar by monofilament suture material
Primary outcome measures
- The incidence of isthmocele by transvaginal ultrasound 6 months after delivery [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Age: 20-45 years old
- Singleton pregnancy.
- Gestational age between 37 completed weeks to 42 weeks.
- Patients undergoing elective primary caesarean section
Exclusion criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Faculty of medicine — Cairo
Identifiers
NCT: NCT06741371 · FMASU MD333/2023