NCT06691750 Clinical Impact of Uterine Repair During Cesarean Section with Barbed Suture on the Incidence of Isthmocele
| NCT ID | NCT06691750 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Clinic of Barcelona |
| Condition | Isthmocele |
| Study Type | INTERVENTIONAL |
| Enrollment | 364 participants |
| Start Date | 2024-11-22 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 364 participants in total. It began in 2024-11-22 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Pregnant women, irrespective of their pregnancy risk, who undergo a cesarean section for any reason will be randomized to one of two suturing techniques: conventional suture or barbed suture for uterine repair after the cesarean section. Following surgery, these patients will be followed up for clinical outcomes, ultrasound evaluation of the uterine scar, and study of the hypoxic-inflammatory environment of the uterine cavity.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06691750 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Isthmocele. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06691750 currently recruiting?
Yes, NCT06691750 is actively recruiting participants. Contact the research team at mula@clinic.cat for enrollment information.
Where is the NCT06691750 trial being conducted?
This trial is being conducted at Barcelona, Spain.
Who is sponsoring the NCT06691750 clinical trial?
NCT06691750 is sponsored by Hospital Clinic of Barcelona. The trial plans to enroll 364 participants.