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RecruitingNCT07790471ERAC-QoRUpdated Aug 27, 2026

Enhanced Recovery Protocol Compliance and Quality of Recovery After Cesarean Delivery

An observational study in Cesarean Section, Postoperative Recovery and Postoperative Pain, sponsored by Bursa City Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Bursa City Hospital · Observational

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
Female
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Study 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. 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.

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Conditions studied

  • Cesarean Section
  • Postoperative Recovery
  • Postoperative Pain

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Keywords

  • Enhanced Recovery After Cesarean Delivery
  • ERAC
  • Obstetric Quality of Recovery
  • ObsQoR-10
  • Spinal Anesthesia
  • Maternal Recovery
  • Preoperative Anxiety
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In context

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

This study's planned enrollment of 150 is above the median of 102 across 683 observational studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Bursa City Hospital is the lead sponsor of 71 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18 years or older
  • Scheduled for elective cesarean delivery
  • Planned spinal anesthesia
  • physical status II or III
  • Ability to read and understand Turkish
  • Provision of written

Exclusion criteria

Exclusion Criteria:

  • 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
  • Severe psychiatric disease
  • Severe neurological disease
  • Inability to communicate
  • Cognitive impairment preventing completion of study questionnaires
  • Refusal to participate
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • High ERAC Compliance

    Women undergoing elective cesarean delivery under spinal anesthesia with adherence to 80% or more of enhanced recovery protocol components.

    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.

    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.

    Other: Assessment of Enhanced Recovery Protocol Compliance

Interventions

  • OtherAssessment of Enhanced Recovery Protocol Compliance

    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.

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What researchers measure

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 delivery

Secondary 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 delivery

  2. 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 delivery

  3. 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 delivery

  4. 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 delivery

  5. Length of Hospital Stay

    Duration of hospital stay from the completion of cesarean delivery until formal hospital discharge, measured in hours.

    Time frame: From cesarean delivery until hospital discharge, assessed up to 7 days

  6. 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.

    Time frame: Before cesarean delivery

  7. 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.

    Time frame: Before cesarean delivery

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared because of participant confidentiality and institutional data protection policies. Only aggregated study results will be published.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07790471
Lead sponsor
Bursa City Hospital
Collaborators
Ulusoy, Emre, M.D.
Responsible party
eralp çevikkalp (Associate Professor of Anesthesiology and Reanimation, M.D., Bursa City Hospital) — Principal investigator
First posted
Aug 27, 2026
Start date
Aug 15, 2026
Primary completion
Oct 15, 2026 (estimated)
Completion
Oct 15, 2026 (estimated)
Last update
Aug 27, 2026

Study contacts

emre ulusoy, MD
Contact
emreulusoy36@gmail.com
05379492799

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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