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.
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.
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.
Parallel
Barbed suture
DeviceSize 0 barbed absorbable monofilament suture with unidirectional spikes that includes a loop in one of its ends, not requiring knots.
Conventional smooth suture
DeviceSize 1 smooth multifilament absorbable polyglactin suture.
Rate of Isthmocele
Rate of isthmocele six months after cesarean section examined by transvaginal ultrasonography with hysterosonography.
Ultrasonographic Measurements of Isthmocele
Ultrasonographic characteristics of isthmocele measured by niche length, niche depth, niche width, residual myometrial thickness (RMT) and niche size (niche depth/niche depth+RMTx100\[%\]).
Intrauterine molecular markers of hypoxia and inflammation
Concentrations of the following biomarkers will be assessed by analyzing an endocavitary lavage of the uterus: VEGF-A (an indirect marker of tissue hypoxia associated with angiogenesis and vasculogenesis), G-CSF, IL-1β, IL-6, IL-10, and TNF-α (inflammatory cytokines), as well as HIF1A (hypoxia-inducible transcription factor).
Symptoms
Evaluation of symptoms related to CSD six months after cesarean section, measured as the presence of one or more of the following: prolonged postpartum bleeding, spotting, abnormal menstrual bleeding, dysmenorrhea, pelvic pain and/or dyspareunia.
Risk factors
Collection of individual data in relation to the patient characteristics and the surgical procedure to evaluate potential risk factors. Individual data: Age at inclusion, ethnicity, educational level, parity, number of cesarean deliveries, history of uterine surgery or other abdominal surgeries, body mass index, smoking status, gestational or pregestational diabetes, hypertension, other medical conditions. Surgical data: Location of the hysterotomy, need for additional hemostatic sutures, need for hemostatic material at the surgical site, requirement for antifibrinolytic or uterotonic treatment to control bleeding, estimated blood loss during the surgery.
Ultrasonographic myometrial texture patterns
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