Enhanced Recovery After Surgery (ERAS) Protocol in Elective Cesarean Sections
NCT ID: NCT07104890
Last Updated: 2025-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
84 participants
INTERVENTIONAL
2022-10-01
2022-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Enhanced Recovery After Emergency Cesarean Section: A Comparative Study Assessing Postoperative Recovery and Outcomes
NCT07242924
Outcomes of Enhanced Recovery After Cesarean (ERAC) Protocol
NCT05786352
ERAS Protocol on Maternal and Fetal Outcomes Following Elective Cesarean Section
NCT06753058
Evaluation of the Incidence of Chronic Post-cesarean Pain as Part of an Enhanced Recovery After Surgery (ERAS) Protocol.
NCT04919408
Implementation of Enhanced Recovery in Women Undergoing Cesarean Delivery
NCT05841888
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
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.
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ERAS Protocol Group
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.
Enhanced Recovery After Surgery (ERAS) Protocol, which includes early oral intake, early mobilization, opioid-sparing multimodal analgesia, prophylactic antiemetics, early urinary catheter removal, an
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.
Standard Care Group
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.
Enhanced Recovery After Surgery (ERAS) Protocol, which includes early oral intake, early mobilization, opioid-sparing multimodal analgesia, prophylactic antiemetics, early urinary catheter removal, an
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Enhanced Recovery After Surgery (ERAS) Protocol, which includes early oral intake, early mobilization, opioid-sparing multimodal analgesia, prophylactic antiemetics, early urinary catheter removal, an
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
Exclusion Criteria
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
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Havva Betül Bacak
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Havva Betül Bacak
M.D
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Bartın City Hospital
Bartın, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Zhang 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GOEAH-ERAS-CS01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.