Comparing single-layer and double-layer uterine closure after cesarean section
Frequency of Isthmocele Following Single- Vs Double-layer Uterine Closure. a Prospective and Retrospective Multicenter Observational Study
University of Udine · NCT06708234
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Udine (other) |
| Locations | 1 site (Udine, Udine) |
| Trial ID | NCT06708234 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are women undergoing elective or emergency cesarean sections.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Udine, Udine
- 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
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.
Conditions: Isthmocele, isthmocele, cesarean section, ultrasound