Enhanced Recovery Protocol After Cesarean Section (ERAC)

Effectiveness of Implementing Enhanced Recovery After Cesarean Section Protocol on Maternal and Neonatal Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section
• Intervention / Treatment: Procedure: Enhanced Recovery after Cesarean protocol of Care; Procedure: Routine hospital 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.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakhalia
    • Al Mansurah, Dakhalia, Egypt, 34511
      • Mansoura University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental :ERAC arm (intervention); The intervention group will receive the Enhanced Recovery After Cesarean (ERAC) protocol of care, consisting of the following components: Preoperative care: Patient education.; Reduced preoperative fasting: solid food will be permitted until 6 hours before surgery, and clear fluids until 2 hours before surgery.; Preoperative carbohydrate loading. Intraoperative care: Antibiotic prophylaxis.; Thermal regulation using active warming methods, warmed intravenous fluids, and maintenance of an appropriate operating room temperature.; Neuraxial anesthesia with strategies to prevent maternal hypotension.; Delayed cord clamping for 30-60 seconds after birth.; Immediate maternal-newborn bonding through skin-to-skin contact and early initiation of breastfeeding in the operating room, when clinically feasible. Postoperative care: • Prophylaxis for pos	Procedure: Enhanced 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
Active Comparator: Routine care arm; The control group will receive routine nursing care only (pre-operative, intraoperative and postoperative).NPO for at least 8 hrs for food and fluid ,immediate cord clamping ,no mutlimodal analgesia ,catheter removal after at least 12 hrs	Procedure: Routine 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal quality of recovery score	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.	at day 0 and 2 weeks postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of intraoperative hypotension	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.	day 0 of surgery
Incidence of intraoperative nausea and vomiting	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.	During cesarean delivery.
Time to first semisolid food intake	Time in hours from completion of cesarean delivery to the first intake of semisolid food.	From completion of surgery until first semisolid food intake during hospitalization.
Time to first ambulation	Time in hours from completion of cesarean delivery until the first postoperative ambulation.	From completion of surgery until first ambulation during hospitalization.
Hospital length of stay	Duration of hospitalization measured in hours from completion of cesarean delivery until hospital discharge.	From completion of surgery until hospital discharge.
Hospital readmission	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.	Within 30 days after surgery.
Neonatal Outcome Measures	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	At 1st and 5th minute after birth.
Neonatal intensive care unit admission	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.	From birth until hospital discharge.
Neonatal birth weight	Neonatal birth weight measured in grams using a calibrated infant weighing scale immediately after birth.	Immediately after birth.

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Noura G El-Gamel, MSc, Mansoura University; Study Chair: Enas S Fathy, Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Actual): September 30, 2025
• Study Completion (Actual): October 30, 2025

Study Registration Dates

• First Submitted: July 14, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Cesarean Section; ERAS; Maternal outcome; ERAC; Neonatal Outcome
• Other Study ID Numbers: ERAC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because the participants' informed consent and institutional ethical approval did not include external sharing of participant-level data. Aggregate study findings will be reported in scientific publications.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No