- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ahmed M Adly, Resident
- Phone Number: 01015727207
- Email: Ahmed.18313583@med.aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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. |
|
Active Comparator: 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of hospital stay
Time Frame: Up to 7 days
|
Duration of hospital stay measured in hours from end of cesarean delivery to hospital discharge |
Up to 7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain score at 6 hours
Time Frame: 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
Time Frame: 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
Time Frame: Up to 48 hours
|
Time in hours from end of surgery to first ambulation |
Up to 48 hours
|
|
Time to first oral intake
Time Frame: 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
Time Frame: Up to 48 hours
|
Time in hours from end of surgery to Foley catheter removal |
Up to 48 hours
|
|
Postpartum hemorrhage
Time Frame: 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
Time Frame: Up to 7 days
|
Number of participants who require packed red blood cells transfusion |
Up to 7 days
|
|
Patient satisfaction score
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ahmed A Abdel-Aleem, prof, Department of Obstetrics and Gynecology Assiut University Hospital Assiut Egypt
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERAS-PlacentaPrevia-Assiut-27
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.