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- Ensaio Clínico NCT07830914
ERAS Protocol for Cesarean Delivery in Women With Placenta Previa
Impact of Enhanced Recovery After Surgery Protocol on Maternal Recovery Patient Satisfaction and Length of Hospital Stay Following Cesarean Delivery in Women With Placenta Previa
This study aims to evaluate the impact of Enhanced Recovery After Surgery protocols on maternal outcomes patient satisfaction and length of hospital stay following cesarean delivery in women with placenta previa. Women scheduled for elective cesarean delivery for placenta previa will be managed either with a standardized ERAS pathway or with conventional routine perioperative care.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Placenta previa is associated with significant maternal morbidity and prolonged hospitalization. Enhanced Recovery After Surgery pathways include patient education preoperative fasting optimization multimodal analgesia early oral intake early mobilization and early urinary catheter removal. This prospective study will include women with singleton pregnancy and sonographic diagnosis of placenta previa scheduled for elective cesarean delivery at Assiut University Hospital. Group A will receive ERAS pathway and Group B will receive conventional care. Outcomes including length of hospital stay postoperative pain time to ambulation time to oral intake and patient satisfaction will be compared.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Ahmed M Adly, Resident
- Número de telefone: 01015727207
- E-mail: Ahmed.18313583@med.aun.edu.eg
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Singleton pregnancy
- Sonographic diagnosis of placenta previa
- Scheduled for elective cesarean delivery
- Ability to provide informed consent
Exclusion Criteria:
- Severe medical diseases affecting postoperative recovery including hypertension and diabetes mellitus
- Hemodynamic instability before surgery
- ICU admission immediately after surgery
- Refusal to participate
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: ERAS Group
Women managed according to the standardized ERAS pathway including preoperative education fasting 2 hours for clear fluids multimodal analgesia early oral intake early mobilization and early urinary catheter removal |
Standardized ERAS pathway for cesarean delivery including preoperative counseling, clear fluids allowed up to 2 hours and solid food fasting for 6 hours, optimization of hemoglobin, multimodal analgesia with scheduled acetaminophen and nonsteroidal anti-inflammatory drugs with limited opioids, prophylaxis for postoperative nausea and vomiting, early oral fluid and solid intake, early mobilization with sitting and standing and ambulation within 6 to 12 hours, early Foley catheter removal within 12 hours when clinically feasible, and standardized discharge planning. This intervention is applied only to the Experimental Arm. |
|
Comparador Ativo: Conventional Care Group
Women managed with routine perioperative care currently practiced in the department |
Routine conventional perioperative care currently practiced at Assiut University Hospital including traditional preoperative fasting, standard analgesia, usual timing of oral intake, mobilization and urinary catheter removal according to physician preference. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Length of hospital stay
Prazo: Up to 7 days
|
Duration of hospital stay measured in hours from end of cesarean delivery to hospital discharge |
Up to 7 days
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Postoperative pain score at 6 hours
Prazo: At 6 hours after surgery
|
Pain score assessed using 0 to 10 Visual Analogue Scale with 0 indicating no pain and 10 indicating worst imaginable pain with higher scores indicating worse pain |
At 6 hours after surgery
|
|
Postoperative pain score at 24 hours
Prazo: At 24 hours after surgery
|
Pain score assessed using 0 to 10 Visual Analogue Scale with 0 indicating no pain and 10 indicating worst imaginable pain with higher scores indicating worse pain |
At 24 hours after surgery
|
|
Time to first ambulation
Prazo: Up to 48 hours
|
Time in hours from end of surgery to first ambulation |
Up to 48 hours
|
|
Time to first oral intake
Prazo: Up to 24 hours
|
Time in hours from end of surgery to first oral fluid intake |
Up to 24 hours
|
|
Time to urinary catheter removal
Prazo: Up to 48 hours
|
Time in hours from end of surgery to Foley catheter removal |
Up to 48 hours
|
|
Postpartum hemorrhage
Prazo: Up to 24 hours
|
Number of participants who develop postpartum hemorrhage with blood loss greater than 1000 milliliters |
Up to 24 hours
|
|
Requirement for blood transfusion
Prazo: Up to 7 days
|
Number of participants who require packed red blood cells transfusion |
Up to 7 days
|
|
Patient satisfaction score
Prazo: At 24 hours after surgery
|
Score on the Quality of Recovery-15 questionnaire scale ranges from 0 to 150 with higher scores indicating better recovery and satisfaction |
At 24 hours after surgery
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Ahmed A Abdel-Aleem, prof, Department of Obstetrics and Gynecology Assiut University Hospital Assiut Egypt
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
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
Outros números de identificação do estudo
- ERAS-PlacentaPrevia-Assiut-27
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