Comparing single-layer and double-layer uterine closure after cesarean section
Official title: Frequency of Isthmocele Following Single- Vs Double-layer Uterine Closure. a Prospective and Retrospective Multicenter Observational Study
Run by University of Udine · NCT06708234 · Data updated 2026-11-12
This study is testing whether using a single or double layer of stitches to close the uterus after a cesarean section affects the chances of developing isthmocele, which can cause problems like bleeding and pelvic pain.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | University of Udine Academic / other |
| Locations | 1 site (Udine, Udine) |
| Status | Recruiting |
| Started | May 9, 2024 |
| Main results expected | May 2025 |
| Study ends | November 2025 |
| Registry record updated | November 27, 2024 |
| Trial ID | NCT06708234 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women undergoing elective or emergency cesarean sections.
✕Probably not a fit
Patients under 18 years old, pregnant at the time of ultrasound assessment, or those who refuse transvaginal ultrasound may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to compare the frequency of isthmocele, a complication following cesarean sections, based on whether a single or double layer suture technique is used during uterine closure. It investigates the relationship between the type of hysterorrhaphy and the development of isthmocele, which can lead to symptoms such as abnormal uterine bleeding and pelvic pain. The study will involve patients undergoing elective or emergency cesarean sections at designated medical centers, with assessments conducted via transvaginal ultrasound to identify the presence of isthmocele post-surgery.
Why it matters
Potential benefit: If successful, this study could provide insights that lead to improved surgical techniques and reduced incidence of isthmocele, enhancing maternal health outcomes.
How similar studies have gone: While the specific comparison of single vs. double-layer closure for isthmocele has not been extensively studied, related research on surgical techniques in cesarean sections has shown varying outcomes.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing elective or emergency/emergency caesarean section at the centres involved. Exclusion Criteria: * Age \<18 years; * Pregnant women at the time of ultrasound assessment; * Refusal to perform transvaginal ultrasound; * Type of hysterorrhaphy performed during surgery not known;
Where it's running
-
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ostetrica e Ginecologica Udine
Udine, Udine, Italy Recruiting
Study contacts
- Study coordinator: Lorenza Driul
- Email: lorenza.driul@uniud.it
- Phone: +00393358385138
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.