Placenta Previa
Conditions
Keywords
Patient satisfaction, ERAS, Enhanced Recovery, Placenta Previa, Length of stay, Assiut
Brief summary
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.
Detailed description
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.
Interventions
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.
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.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | Up to 7 days | Duration of hospital stay measured in hours from end of cesarean delivery to hospital discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain score at 6 hours | 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 |
| Postoperative pain score at 24 hours | 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 |
| Time to first ambulation | Up to 48 hours | Time in hours from end of surgery to first ambulation |
| Time to first oral intake | Up to 24 hours | Time in hours from end of surgery to first oral fluid intake |
| Time to urinary catheter removal | Up to 48 hours | Time in hours from end of surgery to Foley catheter removal |
| Postpartum hemorrhage | Up to 24 hours | Number of participants who develop postpartum hemorrhage with blood loss greater than 1000 milliliters |
| Requirement for blood transfusion | Up to 7 days | Number of participants who require packed red blood cells transfusion |
| Patient satisfaction score | 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 |
Contacts
CONTACTAhmed M Adly, Resident
STUDY_CHAIRAhmed A Abdel-Aleem, prof
Department of Obstetrics and Gynecology Assiut University Hospital Assiut Egypt
Outcome results
None listed