Enhanced Recovery Protocol Compliance and Quality of Recovery After Cesarean Delivery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorBursa City Hospital
About this trial
This prospective observational study will evaluate whether adherence to enhanced recovery after cesarean delivery protocols is associated with postoperative recovery quality in women undergoing elective cesarean delivery under spinal anesthesia. A total of 150 participants will be enrolled. Recovery quality will be assessed using the Turkish version of the Obstetric Quality of Recovery-10 questionnaire at 24 hours after surgery. Pain, opioid use, nausea, mobilization, oral intake, breastfeeding, and patient satisfaction will also be evaluated.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Scheduled for elective cesarean delivery
Planned spinal anesthesia
American Society of Anesthesiologists physical status II or III
Disqualifiers
Emergency cesarean delivery
General anesthesia or conversion from spinal to general anesthesia
Major obstetric hemorrhage
Requirement for postoperative intensive care
Trial population
Adult pregnant women aged 18 years or older undergoing elective cesarean delivery under spinal anesthesia at Bursa City Hospital, Türkiye. Eligible participants will have American Society of Anesthesiologists physical status II or III and will be enrolled consecutively during the study period.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Assessment of Enhanced Recovery Protocol Compliance
Other interventionAdherence to routinely implemented enhanced recovery after cesarean delivery components will be assessed during the preoperative, intraoperative, and postoperative periods. Each completed component will receive one point, and overall adherence will be calculated as a percentage. No additional interventions will be administered.
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: High ERAC Compliance1 intervention
Group B: Moderate ERAC Compliance1 intervention
Group C: Low ERAC Compliance1 intervention
Trial outcomes
Primary outcomes
1
Obstetric Quality of Recovery-10 Score
Postoperative recovery quality will be assessed using the Turkish version of the Obstetric Quality of Recovery-10 questionnaire. Total scores range from 0 to 100, with higher scores indicating better recovery.
Time frame
24 hours after cesarean deliverySecondary outcomes
1
Enhanced Recovery Protocol Compliance
Overall compliance with enhanced recovery protocol components will be calculated as the percentage of completed preoperative, intraoperative, and postoperative components.
Time frame
From the preoperative assessment to 24 hours after cesarean delivery2
Postoperative Pain Intensity
Pain intensity will be assessed using the Numeric Rating Scale, ranging from 0 to 10, with higher scores indicating greater pain intensity.
Time frame
In the recovery unit and at 2, 6, 12, and 24 hours after cesarean delivery3
Rescue Opioid Requirement
The number of participants requiring rescue opioid medication after cesarean delivery will be recorded.
Time frame
During the first 24 hours after cesarean delivery4
Total Amsterdam Preoperative Anxiety and Information Scale Score
The overall Amsterdam Preoperative Anxiety and Information Scale score will be calculated. Scores range from 6 to 30, with higher scores indicating greater anxiety and information needs.
Time frame
Before cesarean deliverySponsors and contacts
Click on the lead sponsor to view all of their trials.
Bursa City Hospital
Lead sponsor
Ulusoy, Emre, M.D.
Collaborator
Source ClinicalTrials.gov