Clinical Impact of Uterine Repair During Cesarean Section with Barbed Suture on the Incidence of Isthmocele

Recruiting now · Not applicable

Conditions studied: Isthmocele, Cesarean Scar Defect, Pelvic Pain, Spotting, Infertility, Uterine Niche, Uterine Abnormal Bleeding, Niche

In brief

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.

Key facts

Study ID

NCT06691750

Run by

Hospital Clinic of Barcelona

People needed

364

Starts

2024-11-22

Expected to finish

2028-05-01

Last updated by the study team

2025-03-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Hospital Clínic de Barcelona — Barcelona, Spain (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.