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Enhanced Recovery Protocol After Cesarean Section (ERAC)

21 июля 2026 г. обновлено: Noura El-Gamel, Mansoura University

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.

Обзор исследования

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Действительный)

108

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый

Принимает здоровых добровольцев

Нет

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Поддерживающая терапия
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Одинокий

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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

• 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
Активный компаратор: 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

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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Maternal quality of recovery score
Временное ограничение: 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.
at day 0 and 2 weeks postoperative

Вторичные показатели результатов

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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Следователи

  • Главный следователь: Noura G El-Gamel, MSc, Mansoura University
  • Учебный стул: Enas S Fathy, Mansoura University

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

1 февраля 2025 г.

Первичное завершение (Действительный)

30 сентября 2025 г.

Завершение исследования (Действительный)

30 октября 2025 г.

Даты регистрации исследования

Первый отправленный

14 июля 2026 г.

Впервые представлено, что соответствует критериям контроля качества

21 июля 2026 г.

Первый опубликованный (Действительный)

22 июля 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

22 июля 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

21 июля 2026 г.

Последняя проверка

1 июля 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Другие идентификационные номера исследования

  • ERAC

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Описание плана IPD

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.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования Enhanced Recovery after Cesarean protocol of Care

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