ERAS Protocol for Cesarean Delivery in Women With Placenta Previa
Impact of Enhanced Recovery After Surgery Protocol on Maternal Recovery Patient Satisfaction and Length of Hospital Stay Following Cesarean Delivery in Women With Placenta Previa
This study aims to evaluate the impact of Enhanced Recovery After Surgery protocols on maternal outcomes patient satisfaction and length of hospital stay following cesarean delivery in women with placenta previa. Women scheduled for elective cesarean delivery for placenta previa will be managed either with a standardized ERAS pathway or with conventional routine perioperative care.
調査の概要
状態
条件
詳細な説明
Placenta previa is associated with significant maternal morbidity and prolonged hospitalization. Enhanced Recovery After Surgery pathways include patient education preoperative fasting optimization multimodal analgesia early oral intake early mobilization and early urinary catheter removal. This prospective study will include women with singleton pregnancy and sonographic diagnosis of placenta previa scheduled for elective cesarean delivery at Assiut University Hospital. Group A will receive ERAS pathway and Group B will receive conventional care. Outcomes including length of hospital stay postoperative pain time to ambulation time to oral intake and patient satisfaction will be compared.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ahmed M Adly, Resident
- 電話番号：01015727207
- メール：Ahmed.18313583@med.aun.edu.eg
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Singleton pregnancy
- Sonographic diagnosis of placenta previa
- Scheduled for elective cesarean delivery
- Ability to provide informed consent
Exclusion Criteria:
- Severe medical diseases affecting postoperative recovery including hypertension and diabetes mellitus
- Hemodynamic instability before surgery
- ICU admission immediately after surgery
- Refusal to participate
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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：ERAS Group
Women managed according to the standardized ERAS pathway including preoperative education fasting 2 hours for clear fluids multimodal analgesia early oral intake early mobilization and early urinary catheter removal |
Standardized ERAS pathway for cesarean delivery including preoperative counseling, clear fluids allowed up to 2 hours and solid food fasting for 6 hours, optimization of hemoglobin, multimodal analgesia with scheduled acetaminophen and nonsteroidal anti-inflammatory drugs with limited opioids, prophylaxis for postoperative nausea and vomiting, early oral fluid and solid intake, early mobilization with sitting and standing and ambulation within 6 to 12 hours, early Foley catheter removal within 12 hours when clinically feasible, and standardized discharge planning. This intervention is applied only to the Experimental Arm. |
|
アクティブコンパレータ：Conventional Care Group
Women managed with routine perioperative care currently practiced in the department |
Routine conventional perioperative care currently practiced at Assiut University Hospital including traditional preoperative fasting, standard analgesia, usual timing of oral intake, mobilization and urinary catheter removal according to physician preference. |
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 |
|---|---|---|
|
Length of hospital stay
時間枠：Up to 7 days
|
Duration of hospital stay measured in hours from end of cesarean delivery to hospital discharge |
Up to 7 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postoperative pain score at 6 hours
時間枠：At 6 hours after surgery
|
Pain score assessed using 0 to 10 Visual Analogue Scale with 0 indicating no pain and 10 indicating worst imaginable pain with higher scores indicating worse pain |
At 6 hours after surgery
|
|
Postoperative pain score at 24 hours
時間枠：At 24 hours after surgery
|
Pain score assessed using 0 to 10 Visual Analogue Scale with 0 indicating no pain and 10 indicating worst imaginable pain with higher scores indicating worse pain |
At 24 hours after surgery
|
|
Time to first ambulation
時間枠：Up to 48 hours
|
Time in hours from end of surgery to first ambulation |
Up to 48 hours
|
|
Time to first oral intake
時間枠：Up to 24 hours
|
Time in hours from end of surgery to first oral fluid intake |
Up to 24 hours
|
|
Time to urinary catheter removal
時間枠：Up to 48 hours
|
Time in hours from end of surgery to Foley catheter removal |
Up to 48 hours
|
|
Postpartum hemorrhage
時間枠：Up to 24 hours
|
Number of participants who develop postpartum hemorrhage with blood loss greater than 1000 milliliters |
Up to 24 hours
|
|
Requirement for blood transfusion
時間枠：Up to 7 days
|
Number of participants who require packed red blood cells transfusion |
Up to 7 days
|
|
Patient satisfaction score
時間枠：At 24 hours after surgery
|
Score on the Quality of Recovery-15 questionnaire scale ranges from 0 to 150 with higher scores indicating better recovery and satisfaction |
At 24 hours after surgery
|
協力者と研究者
スポンサー
捜査官
- スタディチェア：Ahmed A Abdel-Aleem, prof、Department of Obstetrics and Gynecology Assiut University Hospital Assiut Egypt
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
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