Comparing monofilament and multifilament sutures for uterine scar 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
This study tests whether using different types of stitches, monofilament or multifilament, during cesarean sections affects the amount of scarring in the uterus for women aged 20-45.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 20 Years to 45 Years |
| Sex | Female |
| Sponsor | Ain Shams Maternity Hospital Academic / other |
| Locations | 1 site (Cairo, Abbasya) |
| Trial ID | NCT06741371 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of different suture materials, specifically monofilament versus multifilament sutures, on the formation of uterine scars after cesarean sections. It aims to determine which type of suture leads to more scar niche formation, as well as assessing secondary outcomes such as blood loss and the need for additional hemostatic sutures. The study will involve patients aged 20-45 years undergoing elective primary cesarean sections, ensuring a controlled environment to evaluate the effects of the suture materials.
Who should consider this trial
Good fit: Ideal candidates are women aged 20-45 years with singleton pregnancies undergoing elective primary cesarean sections.
Not a fit: Patients with a history of uterine surgery, abnormal placental invasion, uterine anomalies, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques that minimize scar formation, enhancing recovery and future pregnancy outcomes for patients.
How similar studies have performed: While there is limited information on similar studies, the comparison of suture materials in surgical outcomes is a recognized area of investigation, suggesting potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Cairo, Abbasya
- Faculty of medicine — Cairo, Abbasya, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohammed Hamed, Prof
- Phone: 01226067272
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.