このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Enhanced Recovery Protocol After Cesarean Section (ERAC)

2026年7月21日 更新者: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.

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

介入

入学 (実際)

108

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Dakhalia
      • Al Mansurah、Dakhalia、エジプト、34511
        • Mansoura University Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

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

いいえ

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

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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
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:

  • 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
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

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.

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
Maternal quality of recovery score
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Incidence of intraoperative hypotension
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠:Immediately after birth.
Neonatal birth weight measured in grams using a calibrated infant weighing scale immediately after birth.
Immediately after birth.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

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

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年2月1日

一次修了 (実際)

2025年9月30日

研究の完了 (実際)

2025年10月30日

試験登録日

最初に提出

2026年7月14日

QC基準を満たした最初の提出物

2026年7月21日

最初の投稿 (実際)

2026年7月22日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月22日

QC基準を満たした最後の更新が送信されました

2026年7月21日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

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?

いいえ

IPD プランの説明

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.

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

いいえ

米国FDA規制機器製品の研究

いいえ

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。

Enhanced Recovery after Cesarean protocol of Careの臨床試験

購読する