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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ahmed M Adly, Resident
- Numéro de téléphone: 01015727207
- E-mail: Ahmed.18313583@med.aun.edu.eg
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
|
Comparateur actif: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Length of hospital stay
Délai: Up to 7 days
|
Duration of hospital stay measured in hours from end of cesarean delivery to hospital discharge |
Up to 7 days
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Postoperative pain score at 6 hours
Délai: 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
Délai: 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
Délai: Up to 48 hours
|
Time in hours from end of surgery to first ambulation |
Up to 48 hours
|
|
Time to first oral intake
Délai: 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
Délai: Up to 48 hours
|
Time in hours from end of surgery to Foley catheter removal |
Up to 48 hours
|
|
Postpartum hemorrhage
Délai: 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
Délai: Up to 7 days
|
Number of participants who require packed red blood cells transfusion |
Up to 7 days
|
|
Patient satisfaction score
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Ahmed A Abdel-Aleem, prof, Department of Obstetrics and Gynecology Assiut University Hospital Assiut Egypt
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ERAS-PlacentaPrevia-Assiut-27
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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