Impact of Barbed Suture on Uterine Healing After Cesarean Section
Clinical Impact of Uterine Repair During Cesarean Section with Barbed Suture on the Incidence of Isthmocele and Its Ultrasound and Molecular Characteristics: a Randomized Controlled Trial
NA · Hospital Clinic of Barcelona · NCT06691750
This study tests if using barbed sutures instead of regular sutures during cesarean sections helps pregnant women heal better and reduces complications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 364 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Hospital Clinic of Barcelona (other) |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT06691750 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of using barbed sutures versus conventional sutures for uterine repair during cesarean sections. Pregnant women undergoing cesarean delivery at a tertiary care hospital will be randomly assigned to either suturing technique. The study aims to evaluate clinical outcomes, ultrasound assessments of the uterine scar, and the molecular environment within the uterine cavity over a six-month follow-up period. The primary focus is to determine if barbed sutures lead to better healing and lower incidence of isthmocele compared to traditional sutures.
Who should consider this trial
Good fit: Ideal candidates are pregnant women delivering via cesarean section at the Hospital Clinic of Barcelona, regardless of their pregnancy risk.
Not a fit: Patients who deliver vaginally or have a prior diagnosis of isthmocele will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of isthmocele and related complications in women after cesarean delivery.
How similar studies have performed: While the use of barbed sutures is gaining attention, this specific comparison with conventional sutures in the context of cesarean sections is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women who deliver at Hospital Clinic of Barcelona by a planned, intrapartum or urgent cesarean section, irrespective of their pregnancy risk. * Had accepted to participate in the study during the third trimester of gestation. * Patients who accept a 6-month follow-up visit. * Minimal maternal age of 18 years old. Exclusion Criteria: * Patients who end up delivering in another center. * Patients who deliver by vaginal route. * Patients diagnosed with isthmocele prior to the current pregnancy. * Need for histerectomy in the following 6 months after delivery. * Patients with known allergies to any of the components of the barbed suture.
Where this trial is running
Barcelona
- Hospital Clínic de Barcelona — Barcelona, Spain (RECRUITING)
Study contacts
- Study coordinator: Cristina Mula
- Email: mula@clinic.cat
- Phone: +34 635486919
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, Cesarean Scar Defect, Pelvic Pain, Spotting, Infertility, Uterine Niche, Uterine Abnormal Bleeding, Niche