Cesarean Section
Conditions
Keywords
Cesarean Section, Maternal outcome, Neonatal Outcome, ERAS, ERAC
Brief summary
This study aims to evaluate the effectiveness of implementing the Enhanced Recovery After Cesarean (ERAC) protocol on maternal and neonatal outcomes. Research hypotheses To fulfill the aim of the study, the following research hypotheses are formulated: Hypothesis I: Women who receive the ERAC protocol experience faster recovery compared to those who receive routine hospital nursing care. Hypothesis II: Women who receive the ERAC protocol experience fewer maternal and neonatal complications than those who receive routine hospital nursing care.
Detailed description
Cesarean section (CS) remains one of the most common surgical procedures in obstetric practice. Worldwide CS rates have become an important public health concern because of their implications for maternal and neonatal healthcare. In many countries, including Egypt, cesarean delivery rates have increased substantially during recent decades, often exceeding recommended levels. Cesarean section is a lifesaving procedure when medically indicated. Common indications include fetal malpresentation, multiple pregnancy, chorioamnionitis, arrested labor, oligohydramnios, umbilical cord prolapse, cephalopelvic disproportion, eclampsia, and hemolysis, elevated liver enzymes, and low platelet count (HELLP) syndrome. Elective CS may also be influenced by fear of vaginal birth and concerns regarding labor-related complications, including pelvic organ prolapse and perineal injury. Although CS is generally considered safe, it remains associated with several intraoperative and postoperative maternal and neonatal risks. Intraoperative maternal complications include hypotension, local anesthetic toxicity, post-dural puncture headache, nerve injury, endometritis, severe bleeding, and urinary tract or bowel injury. Postoperative complications include abdominal pain, bowel obstruction, incisional hernia, pelvic adhesions, postpartum hemorrhage, deep vein thrombosis, increased risks of placenta previa or placental abruption in subsequent pregnancies, prolonged hospitalization, delayed functional recovery, emotional distress, delayed maternal-infant bonding, and reduced patient satisfaction. Neonatal risks associated with CS include birth injury, persistent tachypnea, respiratory distress syndrome, transient tachypnea of the newborn, low birth weight, low Apgar scores, and admission to the neonatal intensive care unit (NICU). Such complications occur more frequently after emergency CS than after elective CS or vaginal birth. The increasing global rate of CS highlights the need to improve the quality of perioperative care provided to women undergoing cesarean delivery. Evidence-based practices emphasizing patient education, informed consent, and shared decision-making contribute to safer and more individualized maternity care. The Enhanced Recovery After Cesarean (ERAC) protocol standardizes preoperative, intraoperative, and postoperative care to improve recovery and quality of care. The ERAC protocol includes a comprehensive set of evidence-based interventions designed to enhance maternal recovery and reduce maternal and neonatal complications. The pathway extends from the decision for cesarean delivery until hospital discharge. Preoperative care includes patient education, reduced preoperative fasting, maintenance of normothermia, and optimization of hemoglobin levels. Intraoperative care includes prophylactic antibiotics, appropriate fluid preload or co-load, phenylephrine infusion, neuraxial anesthesia with opioid-sparing analgesia, delayed cord clamping, skin-to-skin contact, and early initiation of breastfeeding. Postoperative ERAC care includes prophylaxis for postoperative nausea and vomiting (PONV), multimodal analgesia, early oral intake, early ambulation, early urinary catheter removal, lactation support, and streamlined hospital discharge. The ERAC protocol provides an evidence-based approach to reducing surgical complications, improving maternal outcomes and functional recovery, strengthening maternal-infant bonding, enhancing patient experience, and shortening hospital length of stay.
Interventions
PROCEDUREEnhanced Recovery after Cesarean protocol of Care
• The intervention group will receive the Enhanced Recovery after Cesarean protocol of Care which consists of: Preoperative Care: * Patient education covering the procedure, perioperative expectations, pain management plan, early oral intake and mobilization goals, discharge criteria, and follow-up schedule. * Minimizing fasting: Solid food allowed up to 6 hours and clear fluids up to 2 hours prior to surgery. * Carbohydrate loading: Administration of 45g non-particulate carbohydrate drink up to 2 hours before surgery for non-diabetic mothers. Intraoperative Care: * Antibiotic prophylaxis: Administered within 60 minutes prior to skin incision. * Thermal regulation: Use of active warming methods, warmed IV fluids, and maintaining operating room temperature \>72.8°F (22.7°C). * Anesthesia: Neuraxial anesthesia with hypotension prevention strategies (fluid preloading/co-loading and phenylephrine infusion). * Delayed cord clamping: For 30-60 seconds after birth. * Immediate maternal-newborn
PROCEDURERoutine hospital care
The control group will receive routine preoperative, intraoperative, and postoperative nursing care according to standard hospital practice. Preoperative care: • Fasting from both food and fluids for at least 8 hours before surgery. Intraoperative care: • Immediate umbilical cord clamping after birth. Postoperative care: * Analgesia according to routine hospital practice without a standardized multimodal analgesic regimen. * Urinary catheter removal at least 12 hours after surgery.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
This study will be conducted as a single-blind randomized controlled trial, where participants will be blinded to group allocation.
Intervention model description
Participants in the control group will receive the standard perioperative nursing care routinely provided at the study site, including conventional preoperative, intraoperative, and postoperative practices without a structured protocol. • The intervention group will receive the Enhanced Recovery after Cesarean protocol of Care which consists of: Preoperative Care: * Patient education covering the procedure, perioperative expectations, pain management plan, early oral intake and mobilization goals, discharge criteria, and follow-up schedule. * Minimizing fasting: Solid food allowed up to 6 hours and clear fluids up to 2 hours prior to surgery. * Carbohydrate loading: Administration of 45g non-particulate carbohydrate drink up to 2 hours before surgery for non-diabetic mothers. Intraoperative Care: * Antibiotic prophylaxis: Administered within 60 minutes prior to skin incision. * Thermal regulation: Use of active warming methods, warmed IV fluids, and maintaining operating room temperatu
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Women undergoing planned cesarean delivery. * Scheduled to receive neuraxial anesthesia. * Gestational age of 37 weeks or more. * Singleton pregnancy.
Exclusion criteria
* Women requiring additional interventions outside the Enhanced Recovery After Cesarean (ERAC) pathway, including severe coagulopathy or active infection. * Women expected to require prolonged hospitalization because of a history of uterine rupture, pre-existing hypertension, pregnancy-induced hypertension, or placenta accreta.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal quality of recovery score | at day 0 and 2 weeks postoperative | Maternal quality of recovery will be measured using a 40-item questionnaire. Each item is rated on a three-point Likert scale: 1 = rarely, 2 = sometimes, and 3 = always. Scores are reversed for negatively worded items. Total scores range from 40 to 120, with higher scores indicating better quality of recovery and lower scores indicating poorer quality of recovery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of intraoperative hypotension | day 0 of surgery | Occurrence of maternal hypotension during cesarean delivery, recorded as present or absent and reported as the number and percentage of women in each study group. |
| Incidence of intraoperative nausea and vomiting | During cesarean delivery. | Occurrence of maternal nausea and/or vomiting during cesarean delivery, recorded as present or absent and reported as the number and percentage of women in each study group. |
| Time to first semisolid food intake | From completion of surgery until first semisolid food intake during hospitalization. | Time in hours from completion of cesarean delivery to the first intake of semisolid food. |
| Time to first ambulation | From completion of surgery until first ambulation during hospitalization. | Time in hours from completion of cesarean delivery until the first postoperative ambulation. |
| Hospital length of stay | From completion of surgery until hospital discharge. | Duration of hospitalization measured in hours from completion of cesarean delivery until hospital discharge. |
| Hospital readmission | Within 30 days after surgery. | Occurrence of hospital readmission due to maternal postoperative complications, recorded as present or absent and reported as the number and percentage of women in each study group. |
| Neonatal Outcome Measures | At 1st and 5th minute after birth. | Neonatal condition measured using the Apgar score at 1 minute after birth. The total score ranges from 0 to 10 and will be categorized as reassuring (7-10), moderately abnormal (4-6), or low (0-3), with higher scores indicating better neonatal conditio |
| Neonatal intensive care unit admission | From birth until hospital discharge. | Admission of the newborn to the neonatal intensive care unit, recorded as present or absent and reported as the number and percentage of newborns in each study group. |
| Neonatal birth weight | Immediately after birth. | Neonatal birth weight measured in grams using a calibrated infant weighing scale immediately after birth. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORNoura G El-Gamel, MSc
Mansoura University
STUDY_CHAIREnas S Fathy
Mansoura University
Outcome results
None listed