Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele (CESARIS)
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
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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:
- The use of barbed suture during cesarean delivery leads to a reduction in molecular biomarker levels of hypoxia and inflammation within the uterine cavity.
- The employment of barbed suture is associated with a decrease in the frequency of symptoms related to isthmocele in the short term, or a lower intensity of symptoms if they occur, compared to conventional suture.
- Patients who develop isthmocele after cesarean delivery present predisposing myometrial characteristics and additional risk factors compared to patients with normal healing.
- The study of myometrial texture patterns based on ultrasound images of the uterine wall in the postpartum period following cesarean delivery may provide predictive data regarding the risk of developing isthmocele at six months postpartum.
- The stiffness of the uterine scar measured by the strain ratio (SR) is lower among patients included in the barbed suture group than in patients in the conventional suture group.
- Uterine repair with barbed suture during the cesarean section leads to better perinatal outcomes in the subsequent pregnancies.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Cristina Mula
- Número de telefone: +34 635486919
- E-mail: mula@clinic.cat
Locais de estudo
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Barcelona, Espanha
- Recrutamento
- Hospital Clínic de Barcelona
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Contato:
- Cristina Mula
- Número de telefone: +34 635486919
- E-mail: mula@clinic.cat
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Study Group: Uterine repair with barbed suture
Uterine closure following cesarean section is carried out using an unlocked single-layer barbed suture with an endometrium-free technique. |
Size 0 barbed absorbable monofilament suture with unidirectional spikes that includes a loop in one of its ends, not requiring knots. |
|
Comparador Ativo: Control Group: Uterine repair with conventional smooth suture
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. |
Size 1 smooth multifilament absorbable polyglactin suture. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Rate of Isthmocele
Prazo: Nine to twelve months after cesarean section.
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Rate of isthmocele at nine to twelve months after cesarean section examined by transvaginal ultrasonography with hysterosonography. |
Nine to twelve months after cesarean section.
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Ultrasonographic Measurements of Isthmocele
Prazo: Nine to twelve months after cesarean section.
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Ultrasonographic characteristics of isthmocele measured by niche length, niche depth, niche width, residual myometrial thickness (RMT) and niche size (niche depth/niche depth+RMTx100[%]). |
Nine to twelve months after cesarean section.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Intrauterine molecular markers of hypoxia and inflammation
Prazo: Nine to twelve months after cesarean section.
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Concentrations of the following biomarkers will be assessed by analyzing an endocavitary lavage of the uterus: SDF-1/CXCL12 (an indirect marker of tissue hypoxia), G-CSF, IL-1β, IL-6, IL-10 and TNF-α (inflammatory cytokines). |
Nine to twelve months after cesarean section.
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Symptoms
Prazo: Nine to twelve months after cesarean section.
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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. |
Nine to twelve months after cesarean section.
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Risk factors
Prazo: Through study completion, an average of 2 years.
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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.
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Ultrasonographic myometrial texture patterns
Prazo: Nine to twelve months after cesarean section.
|
Nine to twelve months after cesarean section.
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Stiffness of the uterine scar
Prazo: Nine to twelve months after cesarean section.
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Stiffness differences of the uterine scar between the two groups will be compared by measuring the strain ratio (SR). |
Nine to twelve months after cesarean section.
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Perinatal outcomes in following pregnancies
Prazo: Through study completion, an average of 4 years.
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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.
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Doenças Genitais
- Dor
- Manifestações Neurológicas
- Processos Patológicos
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Doenças uterinas
- Doenças Genitais Femininas
- Hemorragia
- Hemorragia Uterina
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Infertilidade
- Dor pélvica
- Metrorragia
Outros números de identificação do estudo
- HCB/2024/0196
Plano para dados de participantes individuais (IPD)
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