Difference Between Monofilament Versus Multifilament Suture Material in Isthmocele Formation (NCT06741371) | Clinical Trial Compass
RecruitingNot Applicable
Difference Between Monofilament Versus Multifilament Suture Material in Isthmocele Formation
Egypt140 participantsStarted 2024-01-01
Plain-language 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
Who can participate
Age range
20 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The incidence of isthmocele by transvaginal ultrasound 6 months after delivery