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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.
A randomized controlled trial will be conducted among pregnant women, irrespective of their pregnancy risk, undergoing cesarean sections at a tertiary care hospital. Participants will be randomly assigned to one of two groups: the intervention group, which will receive barbed suture for myometrial repair following the cesarean section, or the control group, which will receive conventional smooth suture. This study aims to compare a range of outcomes related to clinical, ultrasonographic, and molecular parameters of the uterine scar and the development of isthmocele.
Main hypothesis: The use of barbed suture for hysterorrhaphy during cesarean section, compared to conventional smooth sutures, results in reduced ischemia and necrosis of the myometrial tissue, facilitating better healing. This is associated with a lower incidence of isthmocele at six months postpartum, and a decrease in its ultrasound dimensions, evaluated by transvaginal ultrasound with hysterosonography.
Secondary hypothesis:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group: Uterine repair with barbed suture | Experimental | Uterine closure following cesarean section is carried out using an unlocked single-layer barbed suture with an endometrium-free technique. |
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| Control Group: Uterine repair with conventional smooth suture | Active Comparator | Uterine repair following cesarean section is performed using a conventional smooth polyglactin suture with a continuous single-layer, endometrium-free technique, in accordance with the standard procedure at our center. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Barbed suture | Device | Size 0 barbed absorbable monofilament suture with unidirectional spikes that includes a loop in one of its ends, not requiring knots. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Isthmocele | Rate of isthmocele six months after cesarean section examined by transvaginal ultrasonography with hysterosonography. | Six months after cesarean section. |
| 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[%]). | Six months after cesarean section. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Six months after cesarean section. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cristina Mula | Contact | +34 635486919 | mula@clinic.cat |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnic de Barcelona | Recruiting | Barcelona | Spain |
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A randomized, controlled, double-blind, two-parallel clinical trial.
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| Conventional smooth suture | Device | Size 1 smooth multifilament absorbable polyglactin suture. |
|
| 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. | Six months after cesarean section. |
| 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. | Through study completion, an average of 2 years. |
| Ultrasonographic myometrial texture patterns | Six months after cesarean section. |
| Stiffness of the uterine scar | Stiffness differences of the uterine scar between the two groups will be compared by measuring the strain ratio (SR). | Six months after cesarean section. |
| Perinatal outcomes in following pregnancies | Perinatal outcomes in subsequent pregnancies will be measured as the presence of one of the following: miscarriage, ectopic pregnancy, uterine rupture, placental accretism, cesarean delivery among others. | Through study completion, an average of 4 years. |
| ID | Term |
|---|---|
| D017699 | Pelvic Pain |
| D008796 | Metrorrhagia |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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