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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Dakhalia
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Al Mansurah、Dakhalia、エジプト、34511
- Mansoura University Hospital
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的: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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アクティブコンパレータ: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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Maternal quality of recovery score
時間枠:at day 0 and 2 weeks postoperative
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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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of intraoperative hypotension
時間枠:day 0 of surgery
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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
時間枠:During cesarean delivery.
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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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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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協力者と研究者
スポンサー
捜査官
- 主任研究者:Noura G El-Gamel, MSc、Mansoura University
- スタディチェア:Enas S Fathy、Mansoura University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- ERAC
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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