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Completed

NCT Number: NCT07720986

Enhanced Recovery Protocol After Cesarean Section

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.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University Hospital

Al Mansurah, Dakhalia, 34511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enhanced Recovery after Cesarean protocol of Care

Procedure
  • 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

Routine hospital care

Procedure

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.

Primary outcomes

  1. Maternal quality of recovery score

    Time frame: 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 outcomes

  1. Incidence of intraoperative hypotension

    Time frame: 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.

  2. Incidence of intraoperative nausea and vomiting

    Time frame: 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.

  3. Time to first semisolid food intake

    Time frame: 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.

  4. Time to first ambulation

    Time frame: From completion of surgery until first ambulation during hospitalization.

    Time in hours from completion of cesarean delivery until the first postoperative ambulation.

  5. Hospital length of stay

    Time frame: From completion of surgery until hospital discharge.

    Duration of hospitalization measured in hours from completion of cesarean delivery until hospital discharge.

  6. Hospital readmission

    Time frame: 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.

  7. Neonatal Outcome Measures

    Time frame: 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

  8. Neonatal intensive care unit admission

    Time frame: 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.

  9. Neonatal birth weight

    Time frame: Immediately after birth.

    Neonatal birth weight measured in grams using a calibrated infant weighing scale immediately after birth.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Acronym: ERAC

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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