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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Ahmed M Adly, Resident
- 전화번호: 01015727207
- 이메일: Ahmed.18313583@med.aun.edu.eg
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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. |
|
활성 비교기: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Length of hospital stay
기간: Up to 7 days
|
Duration of hospital stay measured in hours from end of cesarean delivery to hospital discharge |
Up to 7 days
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Postoperative pain score at 6 hours
기간: 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
기간: 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
기간: Up to 48 hours
|
Time in hours from end of surgery to first ambulation |
Up to 48 hours
|
|
Time to first oral intake
기간: 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
기간: Up to 48 hours
|
Time in hours from end of surgery to Foley catheter removal |
Up to 48 hours
|
|
Postpartum hemorrhage
기간: 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
기간: Up to 7 days
|
Number of participants who require packed red blood cells transfusion |
Up to 7 days
|
|
Patient satisfaction score
기간: 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
|
공동 작업자 및 조사자
수사관
수사관
- 연구 의자: Ahmed A Abdel-Aleem, prof, Department of Obstetrics and Gynecology Assiut University Hospital Assiut Egypt
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- ERAS-PlacentaPrevia-Assiut-27
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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