ERAS Protocol on Maternal and Fetal Outcomes Following Elective Cesarean Section
NCT ID: NCT06753058
Last Updated: 2024-12-31
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
450 participants
INTERVENTIONAL
2021-06-01
2023-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Primary purpose is to learn if implementing ERAS protocol can improve maternal outcomes in pregnant women aged greater than 18 years scheduled to undergo elective CS under spinal anesthesia using patient reported outcome mesaure (PROM).
Secondary purpose is to learn if implementation of maternal ERAS protocol can improve neonatal outcome in terms of nutrition and breastfeeding.
The main questions that aims to answer are maternal recovery outcome measure determined by obstetric quality recovery score (ObsQoR) which has been known as a patient reported outcome mesaure (PROM) and neonatal outcome assessed by pediatricians.
Primary outcome measure is improved maternal recovery in term of ObsQoR in the ERAS pathway.
Secondary outcome measure is improved neonatal outcome in terms of nutrition and breastfeeding in the ERAS pathway.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Features of ERAS implementation and standard care in the study Step 1. Preoperative (Antepartum) Components
1. Enrolled patients were seen in the antenatal clinic to give face to face education including information about fasting, CS and/or anesthesia, antimicrobial prophylaxis, skin washing, breastfeeding preparation and support by the principal researcher anesthesiologist for ERAS pathway to improve patient understanding and engagement in their own care.
2. Principally fasting 6 hours (h) for solids and 2 h for clear fluids was provided. To standardize fasting duration according to the scheduled time of surgery in the ERAS group, parturients who were scheduled for CS before 12:00 PM were allowed to have breakfast at 2:00 AM, while the rest scheduled for CS after 12:00 PM were allowed to have breakfast at 6:00 AM. On the morning of surgery, parturients either diabetic or non-diabetic in the ERAS implemented group were given a carbohydrate solution prepared by the principal researcher anesthesiologist containing 25 g of maltodextrin in 330 mL approximately 2 h prior to surgery.
The control group fasted after 12:00 AM regardless of the scheduled CS time and no carbohydrate solution was administered prior to surgery.
3. Anemia screening and treatment for hemoglobin optimization was done in both groups.
Step 2. Perioperative (Intrapartum) Components
1. Standard intravenous (IV) antibiotic prophylaxis as per hospital guidelines was done in both groups (IV Cefazolin 2 gram in case of no known allergy history).
2. Management of anesthesia/analgesia (neuraxial 100 microgram of morphine and 10 microgram of fentanyl), maintenance of fluid and surgical techniques were similar in both groups. As per our obstetric anesthesia division practice \[16\], weight-height adjusted dose of hyperbaric bupivacaine 0.5% with morphine plus fentanyl was used during co-loading of 500 mL of colloid (VOLUHES, HES 130/0.4, 6% I.V., Polifarma, Türkiye) for spinal anesthesia and spinal anesthesia induced hypotension was treated with 10 mg of ephedrine (only available vasopressor drug in the country) in IV bolus doses in both groups.
3. Despite all parturients in both groups received 10 mg of IV metoclopramide prophylactically, parturients in the ERAS implemented group received IV 1.5 mg of the 5-HT3 antagonist granisetron additionally. In both groups, in case of risk factors for intraoperative and postoperative nausea and vomiting (PONV), IV 4 mg of dexamethasone was added.
4. To maintain normothermia body temperature loss was prevented using under-patient-mattress-blankets and warmers along with the control of the operating theatre temperature.
5. After the delivery of the baby, uterotonics were administered as per hospital guidelines (50 microgram of carbetocin IV bolus was given and followed by 20 IU of oxytocin in 1000 ml of normal saline infusion was started at a rate of 2.5-7.5 IU/ hour) in both groups.
Delayed cord clamping was not performed in any of the groups by the obstetricians.
Step 3. Postoperative Components
1. In both groups who are at risk for deep vein thrombosis, prophylaxis was provided using pneumatic compression stockings.
2. Blood glucose monitoring was conducted only in diabetic patients and those with symptoms of hypoglycemia during follow-up.
3. In the ERAS implemented group, the diet management plan was as follows:
* drinking clear water was started at 2 h postoperatively
* eating liquid diet (regime I or II) was started at 4 h
* Regime I (R-I) is a clear liquid diet that contains pulp-free, grain-free liquid drinks such as sweetened tea, fruit juice, compote water, lemonade, meat and chicken broth.
* Regime II (R-II) is a soft diet that consists of soft, easily chewable and digestible foods such as; light soups, mashed and boiled potatoes, puddings and liquid drinks, etc.
* eating normal diet (regime III-IV) was started at 6 h
In the control group, the oral intake -diet management plan was as follows:
* drinking water at 6 h postoperatively
* eating diet R I-II a few h later
* eating diet R III-IV after 1st flatus
4. Parturients in the ERAS implemented group were encouraged to chew gum with early feeding, while patients in the control group were not.
5. The urinary catheter was removed just before mobilization in the ERAS implemented group, whereas it was removed when urine output reached to 1000 mL as per clinical conventional procedure in the control group.
6. In the ERAS implemented group, mother-baby contact to promote early bonding was established, and both mother and baby were encouraged for breastfeeding. In the control group, only mother-baby contact was facilitated without proactive breastfeeding encouragement.
7. Prior to discharge, both groups were asked to fill out the validated Turkish version of the ObsQoR-11 with 11-point Likert scale. These forms were collected.
Recorded parameters;
* maternal demographics, comorbidities with medications and history (drug allergy, surgical and obstetric)
* preoperative duration of fasting for fluid and solid food, time to intake of 1st postoperative water, regimen I-II and regimen III-IV
* time to mobilization, urinary catheter removal and flatus and LOS for mother (in hours)
* postoperative pain within 24 h of the surgery was assessed for all patients using VAS scores at postoperative 24 h in rest and extra analgesic requirement
* validated Turkish version of 11-item ObsQoR score with an 11-point numerical Likert scale (0 being strongly negative, 10 being strongly positive) resulting maximum score of 110.
* postoperative complications (hypoglycemia, hypotension, PONV)
* newborn demographics and Apgar scores, umbilical cord gas analysis, newborn LOS in days
* need for follow-up in the ward or newborn intensive care unit (NICU) for transient tachypnea of the newborn (TTN) or phototherapy
* status of mother-baby bonding and breastfeeding
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
Unfortunately randomization cannot be done since the strategy for assigning participants to apply ERAS intervention was based on the obstetric team's preference first. The rest of the parturients were regarded as the control group (standard care) who did not receive ERAS intervention.
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
STANDARD CARE (CONTROL)
Standard care as control includes ROUTINE preoperative, peroperative and postoperative approach of the institution for the management of cesraean delivery under spinal anesthesia.
No interventions assigned to this group
ERAS PATHWAY
ERAS INTERVENTION includes 3 steps:
1. preoperative components (face to face education/information about fasting, Cesarean Section and/or anesthesia, antimicrobial prophylaxis, breastfeeding preparation and support, fasting schedule, anemia screening-hemoglobin optimization if needed),
2. peroperative components (antibiotic and antiemetic prophylaxis, management of neuraxial anesthesia, maintenance of normothermia, uterotonic use), 3. postoperative components (early oral intake/urinary catheter removal/mobilization, early mother-newborn bonding and encouraged breastfeeding).
25 gram of maltodextrin in 330 mL , Nutricia Fantomalt 4 Gram, Nutri Gıda Ürünleri San. ve Tic. A.Ş., Istanbul, Türkiye, 2 h prior to surgery.
Although 45 g of different carbohydrate solutions either Gatorade 54 g carbohydrate or clear apple juice 56 g carbohydrate in non-diabetic women have been recommended by SOAP, we preferred 25 g of carbohydrate, fantomalt, nutricia, diluted in the 330 mL in both diabetic and non-diabetic pregnant women.
Mother baby bonding
In the ERAS implemented group, mother-baby contact to promote early bonding was established, and both mother and baby were encouraged for breastfeeding. In the control group, only mother-baby contact was facilitated without proactive breastfeeding encouragement.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
25 gram of maltodextrin in 330 mL , Nutricia Fantomalt 4 Gram, Nutri Gıda Ürünleri San. ve Tic. A.Ş., Istanbul, Türkiye, 2 h prior to surgery.
Although 45 g of different carbohydrate solutions either Gatorade 54 g carbohydrate or clear apple juice 56 g carbohydrate in non-diabetic women have been recommended by SOAP, we preferred 25 g of carbohydrate, fantomalt, nutricia, diluted in the 330 mL in both diabetic and non-diabetic pregnant women.
Mother baby bonding
In the ERAS implemented group, mother-baby contact to promote early bonding was established, and both mother and baby were encouraged for breastfeeding. In the control group, only mother-baby contact was facilitated without proactive breastfeeding encouragement.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gazi University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Berrin Gunaydin
Professor, MD, PhD
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Gazi University School of Medicine Department of Anesthesiology and Reanimation
Ankara, , 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.
Ozdemir MG, Gunaydin B, Bayram M, Hirfanoglu IM. Effect of enhanced recovery after surgery (ERAS) protocol on maternal and fetal outcomes following elective cesarean section: an observational trial. BMC Pregnancy Childbirth. 2025 Apr 29;25(1):517. doi: 10.1186/s12884-025-07583-3.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Decision no: 502/31.05.2021
Identifier Type: -
Identifier Source: org_study_id