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

What this Trial Is About

Researchers are evaluating the effects of two different suturing techniques used during cesarean sections on the healing of the uterine scar and the development of isthmocele, a uterine niche. The study involves pregnant women undergoing cesarean delivery regardless of their pregnancy risk. It aims to compare clinical outcomes, ultrasound features, and molecular markers related to uterine scarring and inflammation, investigating whether barbed sutures improve healing compared to conventional smooth sutures. Participants will be randomly assigned to receive either a barbed absorbable monofilament suture or a conventional smooth multifilament absorbable suture for uterine closure after cesarean section. The barbed suture is a size 0 device with unidirectional spikes that do not require knots, while the conventional suture is size 1 polyglactin. Both techniques use a single-layer, endometrium-free repair method. The study includes follow-up assessments at six months and longer-term monitoring of perinatal outcomes in subsequent pregnancies. During the study, participants will be monitored for clinical outcomes and undergo ultrasound examinations to measure the presence and size of isthmocele at six months postpartum. Molecular markers of hypoxia and inflammation within the uterine cavity will be analyzed, along with assessments of uterine scar stiffness and myometrial texture patterns through ultrasound. The study also tracks symptoms related to isthmocele and evaluates risk factors over an average of two years. Perinatal outcomes in following pregnancies are observed for up to four years, with safety and healing closely followed throughout the study period.

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