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Enhanced Recovery Protocol After Cesarean Section (ERAC)

21 de julio de 2026 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

108

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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

• 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
Comparador activo: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Maternal quality of recovery score
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of intraoperative hypotension
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Immediately after birth.
Neonatal birth weight measured in grams using a calibrated infant weighing scale immediately after birth.
Immediately after birth.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Noura G El-Gamel, MSc, Mansoura University
  • Silla de estudio: Enas S Fathy, Mansoura University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de febrero de 2025

Finalización primaria (Actual)

30 de septiembre de 2025

Finalización del estudio (Actual)

30 de octubre de 2025

Fechas de registro del estudio

Enviado por primera vez

14 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

21 de julio de 2026

Publicado por primera vez (Actual)

22 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

21 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • ERAC

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan 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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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