Cesarean SectionERAC-QoRNCT07790471
Enhanced Recovery Protocol Compliance and Quality of Recovery After Cesarean Delivery
An observational study of Cesarean Section and Postoperative Recovery, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section, Postoperative Recovery, Postoperative Pain
- What is being tested?
- Assessment of Enhanced Recovery Protocol Compliance
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2026to 15 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- Age 18 years or older
- Scheduled for elective cesarean delivery
- Planned spinal anesthesia
- American Society of Anesthesiologists physical status II or III
- Ability to read and understand Turkish
- Provision of written informed consent
Who cannot join
- Emergency cesarean delivery
- General anesthesia or conversion from spinal to general anesthesia
- Major obstetric hemorrhage
- Requirement for postoperative intensive care
- Chronic opioid use
- Chronic pain syndrome
Show all 11Show fewer
- Severe psychiatric disease
- Severe neurological disease
- Inability to communicate
- Cognitive impairment preventing completion of study questionnaires
- Refusal to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bursa City Hospital
Bursa, Nilüfer, 16110
emre ulusoy, MD, 05379492799, emreulusoy36@gmail.com
About this study
Official title: Effect of Enhanced Recovery After Cesarean Delivery Protocol Compliance on Postoperative Quality of Recovery in Patients Undergoing Cesarean Delivery Under Spinal Anesthesia: A Prospective Observational Study
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.
- Conditions
- Cesarean Section, Postoperative Recovery, Postoperative Pain
- Being tested
- Assessment of Enhanced Recovery Protocol Compliance
- Keywords
- Enhanced Recovery After Cesarean Delivery, ERAC, Obstetric Quality of Recovery, ObsQoR-10, Spinal Anesthesia, Maternal Recovery, Preoperative Anxiety
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of Enhanced Recovery Protocol ComplianceOther
Adherence 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.
| Study group | Role | What they receive |
|---|---|---|
| High ERAC Compliance | Women undergoing elective cesarean delivery under spinal anesthesia with adherence to 80% or more of enhanced recovery protocol components. Receives: Other: Assessment of Enhanced Recovery Protocol Compliance | |
| Moderate ERAC Compliance | Women undergoing elective cesarean delivery under spinal anesthesia with adherence to 60% to 79% of enhanced recovery protocol components. Receives: Other: Assessment of Enhanced Recovery Protocol Compliance | |
| Low ERAC Compliance | Women undergoing elective cesarean delivery under spinal anesthesia with adherence to less than 60% of enhanced recovery protocol components. Receives: Other: Assessment of Enhanced Recovery Protocol Compliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours after cesarean delivery
Secondary outcomes (7)
Enhanced Recovery Protocol Compliance
Overall compliance with enhanced recovery protocol components will be calculated as the percentage of completed preoperative, intraoperative, and postoperative components.
Measured: From the preoperative assessment to 24 hours after cesarean delivery
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.
Measured: In the recovery unit and at 2, 6, 12, and 24 hours after cesarean delivery
Rescue Opioid Requirement
The number of participants requiring rescue opioid medication after cesarean delivery will be recorded.
Measured: During the first 24 hours after cesarean delivery
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.
Measured: Before cesarean delivery
Length of Hospital Stay
Duration of hospital stay from the completion of cesarean delivery until formal hospital discharge, measured in hours.
Measured: From cesarean delivery until hospital discharge, assessed up to 7 days
Preoperative Information Requirement
Preoperative information needs will be evaluated using the information subscale of the Amsterdam Preoperative Anxiety and Information Scale. Scores range from 2 to 10, with higher scores indicating greater information needs.
Measured: Before cesarean delivery
Preoperative Anxiety
Preoperative anxiety will be evaluated using the anxiety subscale of the Amsterdam Preoperative Anxiety and Information Scale. Scores range from 4 to 20, with higher scores indicating greater anxiety.
Measured: Before cesarean delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start15 Aug 2026
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Collaborators
- Ulusoy, Emre, M.D.
- Responsible party
- Principal investigator, eralp çevikkalp, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790471
- Sponsor's protocol ID
- BSHE6
- Acronym
- ERAC-QoR
- Status last verified
- Aug 2026
- First submitted
- 23 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because of participant confidentiality and institutional data protection policies. Only aggregated study results will be published.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Enhanced Recovery After Cesarean Delivery Protocol Compliance on Postoperative Quality of Recovery in Patients Undergoing Cesarean Delivery Under Spinal Anesthesia: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07790471
- Acronym / sponsor ID
- ERAC-QoR / BSHE6
- Conditions
- Cesarean Section, Postoperative Recovery, Postoperative Pain
- Keywords
- Enhanced Recovery After Cesarean Delivery, ERAC, Obstetric Quality of Recovery, ObsQoR-10, Spinal Anesthesia, Maternal Recovery, Preoperative Anxiety
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Bursa City HospitalOther government
- Collaborators
- Ulusoy, Emre, M.D.
- Study start
- 15 Aug 2026 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High ERAC Compliance | – | Other: Assessment of Enhanced Recovery Protocol ComplianceWomen undergoing elective cesarean delivery under spinal anesthesia with adherence to 80% or more of enhanced recovery protocol components. |
| Moderate ERAC Compliance | – | Other: Assessment of Enhanced Recovery Protocol ComplianceWomen undergoing elective cesarean delivery under spinal anesthesia with adherence to 60% to 79% of enhanced recovery protocol components. |
| Low ERAC Compliance | – | Other: Assessment of Enhanced Recovery Protocol ComplianceWomen undergoing elective cesarean delivery under spinal anesthesia with adherence to less than 60% of enhanced recovery protocol components. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (6 listed)
- Age 18 years or older
- Scheduled for elective cesarean delivery
- Planned spinal anesthesia
- American Society of Anesthesiologists physical status II or III
- Ability to read and understand Turkish
Key exclusion criteria (11 listed)
- Emergency cesarean delivery
- General anesthesia or conversion from spinal to general anesthesia
- Major obstetric hemorrhage
- Requirement for postoperative intensive care
- Chronic opioid use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of Enhanced Recovery Protocol ComplianceAdherence 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. | Other | High ERAC Compliance, Low ERAC Compliance, Moderate ERAC Compliance |
Primary outcome
Obstetric Quality of Recovery-10 Score
Time frame: 24 hours after cesarean delivery
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.
7 secondary outcomes
Enhanced Recovery Protocol Compliance
Time frame: From the preoperative assessment to 24 hours after cesarean delivery
Postoperative Pain Intensity
Time frame: In the recovery unit and at 2, 6, 12, and 24 hours after cesarean delivery
Rescue Opioid Requirement
Time frame: During the first 24 hours after cesarean delivery
Total Amsterdam Preoperative Anxiety and Information Scale Score
Time frame: Before cesarean delivery
Length of Hospital Stay
Time frame: From cesarean delivery until hospital discharge, assessed up to 7 days
Preoperative Information Requirement
Time frame: Before cesarean delivery
Preoperative Anxiety
Time frame: Before cesarean delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because of participant confidentiality and institutional data protection policies. Only aggregated study results will be published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section and Postoperative Recovery, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact emre ulusoy, MD (05379492799, emreulusoy36@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obstetric Quality of Recovery-10 Score (time frame: 24 hours after cesarean delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.