- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07720986
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Dakhalia
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Al Mansurah, Dakhalia, Egypt, 34511
- Mansoura University Hospital
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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:
Intraoperative care:
Postoperative care: • Prophylaxis for pos |
• The intervention group will receive the Enhanced Recovery after Cesarean protocol of Care which consists of: Preoperative Care:
Intraoperative Care:
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Aktivní komparátor: 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
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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:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Maternal quality of recovery score
Časové okno: 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.
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at day 0 and 2 weeks postoperative
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Incidence of intraoperative hypotension
Časové okno: 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.
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day 0 of surgery
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Incidence of intraoperative nausea and vomiting
Časové okno: 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.
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During cesarean delivery.
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Time to first semisolid food intake
Časové okno: From completion of surgery until first semisolid food intake during hospitalization.
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Time in hours from completion of cesarean delivery to the first intake of semisolid food.
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From completion of surgery until first semisolid food intake during hospitalization.
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Time to first ambulation
Časové okno: From completion of surgery until first ambulation during hospitalization.
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Time in hours from completion of cesarean delivery until the first postoperative ambulation.
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From completion of surgery until first ambulation during hospitalization.
|
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Hospital length of stay
Časové okno: From completion of surgery until hospital discharge.
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Duration of hospitalization measured in hours from completion of cesarean delivery until hospital discharge.
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From completion of surgery until hospital discharge.
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Hospital readmission
Časové okno: Within 30 days after surgery.
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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.
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Within 30 days after surgery.
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Neonatal Outcome Measures
Časové okno: At 1st and 5th minute after birth.
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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
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At 1st and 5th minute after birth.
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Neonatal intensive care unit admission
Časové okno: From birth until hospital discharge.
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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.
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From birth until hospital discharge.
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Neonatal birth weight
Časové okno: Immediately after birth.
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Neonatal birth weight measured in grams using a calibrated infant weighing scale immediately after birth.
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Immediately after birth.
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Noura G El-Gamel, MSc, Mansoura University
- Studijní židle: Enas S Fathy, Mansoura University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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