Elective Cesarean SectionERAS-CSNCT07104890
Enhanced Recovery After Surgery (ERAS) Protocol in Elective Cesarean Sections
A study testing Enhanced Recovery After Surgery (ERAS) Protocol, which includes early oral intake, early mobilization, opioid-sparing multimodal analgesia, prophylactic antiemetics, early urinary catheter removal, an in people with Elective Cesarean Section and Postoperative Recovery, run by Havva Betül Bacak at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the effect of the Enhanced Recovery After Surgery (ERAS) protocol on early postoperative recovery in women undergoing elective cesarean section. Eighty-four pregnant women, aged 18 years or older, at 37 weeks of gestation or beyond, without chronic medical conditions, and classified as ASA I-II… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Elective Cesarean Section, Postoperative Recovery, Enhanced Recovery After Surgery (ERAS)
- What is being tested?
- Enhanced Recovery After Surgery (ERAS) Protocol, which includes early oral intake, early mobilization, opioid-sparing multimodal analgesia, prophylactic antiemetics, early urinary catheter removal, an
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women aged 18 years or older
- Gestational age ≥37 weeks
- Classified as ASA I or ASA II
- Scheduled for elective cesarean section under spinal anesthesia
- Able and willing to provide informed consent
- No chronic systemic diseases
Who cannot join
- Age <18 years
- Gestational age <37 weeks
- Emergency cesarean delivery
- ASA III or higher
- Presence of obstetric complications (e.g., preeclampsia, placenta previa, placental abruption, fetal distress)
- Chronic comorbidities (e.g., diabetes, hypertension, cardiac or pulmonary disease)
- Declines spinal anesthesia or unable to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Enhanced Recovery After Surgery (ERAS) Protocol on Postoperative Recovery in Elective Cesarean Sections
This study evaluates the effect of the Enhanced Recovery After Surgery (ERAS) protocol on early postoperative recovery in women undergoing elective cesarean section.
Eighty-four pregnant women, aged 18 years or older, at 37 weeks of gestation or beyond, without chronic medical conditions, and classified as ASA I-II, were enrolled. Participants were randomly assigned to either:
Read more
ERAS group - received the ERAS protocol, including early oral intake, early mobilization, multimodal analgesia, and enhanced perioperative care
Control group - received standard perioperative cesarean section care
The study compared breastfeeding initiation time, gas passage, oral intake, mobilization time, and postoperative pain scores (VAS) between the two groups.
The aim is to determine whether ERAS can accelerate recovery, reduce pain, and improve maternal comfort after elective cesarean delivery.
Read the detailed description
Enhanced Recovery After Surgery (ERAS) protocols aim to accelerate postoperative recovery, reduce complications, and shorten hospital stays. While ERAS has been widely implemented in general and gynecologic surgeries, its application in obstetric surgery, particularly elective cesarean delivery, remains limited.
This single-center, prospective, randomized clinical trial was conducted at the University of Health Sciences, Istanbul Gaziosmanpasa Training and Research Hospital, between October 2022 and December 2022. Eighty-four women scheduled for elective cesarean section were enrolled. Eligible participants were 18 years or older, at ≥37 weeks of gestation, ASA I-II, without chronic comorbidities, and provided written informed consent.
Participants were randomized (1:1) into two groups:
ERAS group: Managed with ERAS protocol including early oral intake, early mobilization, multimodal analgesia with opioid-sparing strategies, prophylactic antiemetics, early urinary catheter removal, and gum chewing to stimulate bowel function.
Control group: Managed with standard perioperative cesarean care including delayed oral intake, standard pain management, and later mobilization.
Primary outcomes included breastfeeding initiation time, gas passage, time to oral intake, mobilization time, and postoperative pain scores (VAS at 24 and 48 hours). Secondary outcomes included nausea-vomiting incidence and overall postoperative recovery profile.
The study aims to determine whether ERAS protocols improve postoperative recovery and patient comfort after elective cesarean section and to support the implementation of ERAS as a standard in obstetric surgery.
- Being tested
- Enhanced Recovery After Surgery (ERAS) Protocol, which includes early oral intake, early mobilization, opioid-sparing multimodal analgesia, prophylactic antiemetics, early urinary catheter removal, an
- Keywords
- Cesarean Section, Elective Cesarean, Enhanced Recovery After Surgery, ERAS, Postoperative Recovery, Early Mobilization, Postoperative Pain, Multimodal Analgesia, Obstetric Surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Recovery After Surgery (ERAS) Protocol, which includes early oral intake, early mobilization, opioid-sparing multimodal analgesia, prophylactic antiemetics, early urinary catheter removal, anBehavioural
The Enhanced Recovery After Surgery (ERAS) Protocol for elective cesarean section includes a multimodal perioperative care approach aimed at accelerating postoperative recovery. Key components are early oral intake, early mobilization, opioid-sparing multimodal analgesia, prophylactic antiemetics, early removal of the urinary catheter, and gum chewing to stimulate bowel function. This protocol is compared with Standard Perioperative Cesarean Care, which involves overnight fasting, delayed oral intake until bowel function returns, conventional analgesia, later mobilization, and routine catheter removal.
| Study group | Role | What they receive |
|---|---|---|
| ERAS Protocol Group | Experimental | Participants in this arm will receive the Enhanced Recovery After Surgery (ERAS) protocol during elective cesarean section. The ERAS protocol includes early oral intake, early mobilization, opioid-sparing multimodal analgesia, prophylactic antiemetics, early urinary catheter removal, and gum chewing to stimulate bowel function. Postoperative outcomes such as breastfeeding initiation, gas passage, oral intake time, mobilization, and VAS pain scores will be evaluated. Receives: Behavioral: Enhanced Recovery After Surgery (ERAS) Protocol, which includes early oral intake, early mobilization, opioid-sparing multimodal analgesia, prophylactic antiemetics, early urinary catheter removal, an |
| Standard Care Group | Active comparator | Participants in this arm will receive standard perioperative cesarean care, which includes overnight fasting, delayed oral intake until gas passage, routine analgesia with paracetamol, NSAIDs and opioids as needed, later urinary catheter removal, and routine postoperative mobilization. Outcomes will be assessed similarly to the ERAS group. Receives: Behavioral: Enhanced Recovery After Surgery (ERAS) Protocol, which includes early oral intake, early mobilization, opioid-sparing multimodal analgesia, prophylactic antiemetics, early urinary catheter removal, an |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Mobilization After Cesarean Section
Time from the end of elective cesarean section surgery to the patient's first ambulation, measured in hours. Early mobilization reflects enhanced postoperative recovery and is a key indicator of the ERAS protocol's effectiveness.
Measured: Within 24 hours postoperatively
Secondary outcomes (1)
Incidence of Postoperative Nausea and Vomiting
Assessment of the presence and duration of postoperative nausea and vomiting (PONV) following elective cesarean section. Nausea and vomiting episodes will be recorded and analyzed to compare the incidence between the ERAS protocol group and the standard care group.
Measured: Within 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start1 Oct 2022
- Primary completion1 Nov 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Elective 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-center, prospective, randomized, parallel-group clinical trial. Participants were randomly assigned in a 1:1 ratio to either the ERAS protocol group or the standard care control group. Both groups were followed concurrently for postoperative recovery outcomes after elective cesarean section.
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Havva Betül Bacak
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Havva Betül Bacak, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104890
- Sponsor's protocol ID
- GOEAH-ERAS-CS01
- Acronym
- ERAS-CS
- Status last verified
- Jul 2025
- First submitted
- 29 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study is single-center, involves a small sample size of 84 participants, and contains sensitive obstetric patient information. Only de-identified summary data will be reported in publications.
Publications
Khalafallah AM, Susic N, Shah KH, Knott MV, Berke CN, Gurses ME, Lu VM, Ivan ME, Komotar RJ, Shah AH. Evaluating safety and feasibility of same-day discharge after laser interstitial thermal therapy: a pilot study with a matched control group. J Neurooncol. 2025 Sep;174(2):341-347. doi: 10.1007/s11060-025-05055-4. Epub 2025 May 12.
PubMed 40355785Zhang X, Ruan Y, Yuan Y, Li K. Is it necessary to maintain high adherence to enhanced recovery after surgery (ERAS) protocols?-A systematic review and meta-analysis. Curr Probl Surg. 2025 Aug;69:101814. doi: 10.1016/j.cpsurg.2025.101814. Epub 2025 May 30. No abstract available.
PubMed 40716849
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Enhanced Recovery After Surgery (ERAS) Protocol on Postoperative Recovery in Elective Cesarean Sections
- ClinicalTrials.gov ID
- NCT07104890
- Acronym / sponsor ID
- ERAS-CS / GOEAH-ERAS-CS01
- Keywords
- Cesarean Section, Elective Cesarean, Enhanced Recovery After Surgery, ERAS, Postoperative Recovery, Early Mobilization, Postoperative Pain, Multimodal Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Havva Betül BacakOther government
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 5 Aug 2025 (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 study evaluates the effect of the Enhanced Recovery After Surgery (ERAS) protocol on early postoperative recovery in women undergoing elective cesarean section.
Eighty-four pregnant women, aged 18 years or older, at 37 weeks of gestation or beyond, without chronic medical conditions, and classified as ASA I-II, were enrolled. Participants were randomly assigned to either:
ERAS group - received the ERAS protocol, including early oral intake, early mobilization, multimodal analgesia, and enhanced perioperative care
Control group - received standard perioperative cesarean section care
The study compared breastfeeding initiation time, gas passage, oral intake, mobilization time, and postoperative pain scores (VAS) between the two groups.
The aim is to determine whether ERAS can accelerate recovery, reduce pain, and improve maternal comfort after elective cesarean delivery.
Detailed description
Enhanced Recovery After Surgery (ERAS) protocols aim to accelerate postoperative recovery, reduce complications, and shorten hospital stays. While ERAS has been widely implemented in general and gynecologic surgeries, its application in obstetric surgery, particularly elective cesarean delivery, remains limited.
This single-center, prospective, randomized clinical trial was conducted at the University of Health Sciences, Istanbul Gaziosmanpasa Training and Research Hospital, between October 2022 and December 2022. Eighty-four women scheduled for elective cesarean section were enrolled. Eligible participants were 18 years or older, at ≥37 weeks of gestation, ASA I-II, without chronic comorbidities, and provided written informed consent.
Participants were randomized (1:1) into two groups:
ERAS group: Managed with ERAS protocol including early oral intake, early mobilization, multimodal analgesia with opioid-sparing strategies, prophylactic antiemetics, early urinary catheter removal, and gum chewing to stimulate bowel function.
Control group: Managed with standard perioperative cesarean care including delayed oral intake, standard pain management, and later mobilization.
Primary outcomes included breastfeeding initiation time, gas passage, time to oral intake, mobilization time, and postoperative pain scores (VAS at 24 and 48 hours). Secondary outcomes included nausea-vomiting incidence and overall postoperative recovery profile.
The study aims to determine whether ERAS protocols improve postoperative recovery and patient comfort after elective cesarean section and to support the implementation of ERAS as a standard in obstetric surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single-center, prospective, randomized, parallel-group clinical trial. Participants were randomly assigned in a 1:1 ratio to either the ERAS protocol group or the standard care control group. Both groups were followed concurrently for postoperative recovery outcomes after elective cesarean section.
| Arm | Type | Receives |
|---|---|---|
| ERAS Protocol Group | Experimental | Behavioral: Enhanced Recovery After Surgery (ERAS) Protocol, which includes early oral intake, early mobilization, opioid-sparing multimodal analgesia, prophylactic antiemetics, early urinary catheter removal, anParticipants in this arm will receive the Enhanced Recovery After Surgery (ERAS) protocol during elective cesarean section. The ERAS protocol includes early oral intake, early mobilization, opioid-sparing multimodal analgesia, prophylactic antiemetics, early urinary catheter removal, and gum chewing to stimulate bowel function. Postoperative outcomes such as breastfeeding initiation, gas passage, oral intake time, mobilization, and VAS pain scores will be evaluated. |
| Standard Care Group | Active comparator | Behavioral: Enhanced Recovery After Surgery (ERAS) Protocol, which includes early oral intake, early mobilization, opioid-sparing multimodal analgesia, prophylactic antiemetics, early urinary catheter removal, anParticipants in this arm will receive standard perioperative cesarean care, which includes overnight fasting, delayed oral intake until gas passage, routine analgesia with paracetamol, NSAIDs and opioids as needed, later urinary catheter removal, and routine postoperative mobilization. Outcomes will be assessed similarly to the ERAS group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pregnant women aged 18 years or older
- Gestational age ≥37 weeks
- Classified as ASA I or ASA II
- Scheduled for elective cesarean section under spinal anesthesia
- Able and willing to provide informed consent
Key exclusion criteria (7 listed)
- Age <18 years
- Gestational age <37 weeks
- Emergency cesarean delivery
- ASA III or higher
- Presence of obstetric complications (e.g., preeclampsia, placenta previa, placental abruption, fetal distress)
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 |
|---|---|---|
| Enhanced Recovery After Surgery (ERAS) Protocol, which includes early oral intake, early mobilization, opioid-sparing multimodal analgesia, prophylactic antiemetics, early urinary catheter removal, anThe Enhanced Recovery After Surgery (ERAS) Protocol for elective cesarean section includes a multimodal perioperative care approach aimed at accelerating postoperative recovery. Key components are early oral intake, early mobilization, opioid-sparing multimodal analgesia, prophylactic antiemetics, early removal of the urinary catheter, and gum chewing to stimulate bowel function. This protocol is compared with Standard Perioperative Cesarean Care, which involves overnight fasting, delayed oral intake until bowel function returns, conventional analgesia, later mobilization, and routine catheter removal. | Behavioural | ERAS Protocol Group, Standard Care Group |
Primary outcome
Time to First Mobilization After Cesarean Section
Time frame: Within 24 hours postoperatively
Time from the end of elective cesarean section surgery to the patient's first ambulation, measured in hours. Early mobilization reflects enhanced postoperative recovery and is a key indicator of the ERAS protocol's effectiveness.
1 secondary outcome
Incidence of Postoperative Nausea and Vomiting
Time frame: Within 48 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Results publication: PubMed 40355785Khalafallah AM, Susic N, Shah KH, Knott MV, Berke CN, Gurses ME, Lu VM, Ivan ME, Komotar RJ, Shah AH. Evaluating safety and feasibility of same-day discharge after laser interstitial thermal therapy: a pilot study with a matched control group. J Neurooncol. 2025 Sep;174(2):341-347. doi: 10.1007/s11060-025-05055-4. Epub 2025 May 12.
- Results publication: PubMed 40716849Zhang X, Ruan Y, Yuan Y, Li K. Is it necessary to maintain high adherence to enhanced recovery after surgery (ERAS) protocols?-A systematic review and meta-analysis. Curr Probl Surg. 2025 Aug;69:101814. doi: 10.1016/j.cpsurg.2025.101814. Epub 2025 May 30. No abstract available.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study is single-center, involves a small sample size of 84 participants, and contains sensitive obstetric patient information. Only de-identified summary data will be reported in publications.
Related trials for Elective Cesarean Section
Not yet recruitingPhase 4
Oxytocin Bolus Versus Infusion in High-Risk Patients Undergoing Elective Cesarean Section (INBOX-HR)
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Maternal and Fetal Outcomes in Elective vs Emergency Cesarean Section
Maternal and Fetal Outcomes in Elective vs Emergency Cesarean Section
Not yet recruitingObservational study
Gastric Ultrasound Before Elective Cesarean Section
Gastric Ultrasound, Elective Cesarean Section
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Recovery After Surgery (ERAS) Protocol, which includes early oral intake, early mobilization, opioid-sparing multimodal analgesia, prophylactic antiemetics, early urinary catheter removal, an in people with Elective Cesarean Section and Postoperative Recovery, run by Havva Betül Bacak 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 7 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: finished, as of the sponsor's last update on 5 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Mobilization After Cesarean Section (time frame: Within 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07104890, which also lists 2 linked publications.
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 5 Aug 2025; AzTrials last refreshed its copy on 31 Oct 2026.