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临床试验/NCT02956616
NCT02956616已完成2 期

Enhanced Recovery at Cesarean Birth to Improve Postoperative Outcomes and Reduce Postoperative Length of Stay

Montefiore Medical Center1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2017年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
118
试验地点
1
主要终点
Discharge on Postoperative Day #2

研究概览

简要总结

To determine whether women randomized to an enhanced recovery program will have improved postoperative outcomes including improved breastfeeding initiation and continuation, reduction in hospital length of stay without compromising patient satisfaction in comparison to standard postoperative recovery interventions.

详细描述

The investigators hypothesize that an enhanced recovery program which includes several evidence based interventions at the time of cesarean birth in obstetrics will promote early ambulation, resumption of diet and initiation of breastfeeding, and reduce postoperative hospital length of stay.

Enhanced Recovery Protocol Components:

  1. Provide preoperative education about the perioperative recovery experience including postoperative analgesia, thromboprophylaxis and breastfeeding education

  2. Minimize preoperative starvation times

  3. Moderate amount of clears up to 2 hours prior to anesthesia

  4. Solid foods up to 6-8 hours prior to anesthesia

  5. Prophylactic antibiotics

  6. Venous thromboembolism prophylaxis (mechanical) initiated at the time of cesarean birth and continued postoperatively

  7. Chewing gum (Xylitol) to reduce postoperative ileus

  8. Routine administration of Non-steroidal anti-inflammatory drug, Ketorolac, 15mg every hour for 24 hours postoperatively to minimize postoperative narcotic use

  9. Early initiation of feeding after cesarean, immediately for clears, 30 minutes for regular diet as tolerated

  10. Early removal of urinary catheter (12 hours postoperatively)

  11. Early removal of dressing (6 hours postoperatively)

  12. Early mobilization at 12 hours after delivery

  13. Early skin-to- skin/breastfeeding initiation

  14. Early incentive spirometry

Currently, patients are encouraged to ambulate on the first post-operative day, but it is largely left up to the patient when to actually begin to ambulate. They are similarly offered a diet on the first postoperative day but are not encouraged to eat. Breastfeeding is more systematically encouraged early as part of Montefiore's effort to get baby friendly designation. And finally, patients are typically discharged on postoperative day number three unless complications arise in the newborn or the mother. As part of this study, patients in both the enhanced recovery and usual care group will be offered the opportunity to be discharged from the hospital on postoperative day number 2 if their recovery is progressing well and if they choose not to leave then they will be encouraged to return home on postoperative day number 3 according to the current standard of care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women undergoing a non-urgent or elective cesarean delivery >37 weeks gestation

排除标准

  • Women undergoing an urgent or emergent cesarean birth
  • Women less than 18 years old
  • Patients receiving general anesthesia
  • Abnormally adherent placenta (Placenta Accreta) or expected excessive blood loss (Placenta accreta)
  • Pre-existing essential hypertension or hypertensive disorders of pregnancy (preeclampsia, eclampsia, HELLP)
  • Chronic or acute renal impairment
  • Bleeding disorders or platelet dysfunction
  • Peptic ulcer disease or gastrointestinal bleeding
  • Known hypersensitivity to ketorolac (toradol)
  • Active infection at the time of cesarean
  • Cesarean birth prior to 37 weeks
  • Women in significant pain in labor

研究组 & 干预措施

Enhanced Recovery

Experimental

Postoperative recovery will follow the usual service protocols as if the patient were not in the study with the exception of components of the enhanced recovery protocol (detailed previously), which will include several evidence-based recommendations including early ambulation, early diet initiation, early removal of urinary catheter, early removal of postoperative dressing. Additionally, participants in this group will receive intravenous ketorolac for pain control and Xylitol chewing gum for improvement of postoperative gastrointestinal function.

干预措施: ketorolac (Drug)

Enhanced Recovery

Experimental

Postoperative recovery will follow the usual service protocols as if the patient were not in the study with the exception of components of the enhanced recovery protocol (detailed previously), which will include several evidence-based recommendations including early ambulation, early diet initiation, early removal of urinary catheter, early removal of postoperative dressing. Additionally, participants in this group will receive intravenous ketorolac for pain control and Xylitol chewing gum for improvement of postoperative gastrointestinal function.

干预措施: Chewing Gum (Other)

Enhanced Recovery

Experimental

Postoperative recovery will follow the usual service protocols as if the patient were not in the study with the exception of components of the enhanced recovery protocol (detailed previously), which will include several evidence-based recommendations including early ambulation, early diet initiation, early removal of urinary catheter, early removal of postoperative dressing. Additionally, participants in this group will receive intravenous ketorolac for pain control and Xylitol chewing gum for improvement of postoperative gastrointestinal function.

干预措施: Enhanced Recovery Protocol (Procedure)

Routine Perioperative Care

Active Comparator

Postoperative recovery will follow the usual service protocols at our institution. Participants in this group may receive intravenous ketorolac (toradol) for pain control

干预措施: ketorolac (Drug)

结局指标

主要结局

Discharge on Postoperative Day #2

时间窗: Until patient's day of hospital discharge or a maximum of one month from cesarean delivery

Number of patients discharged on postoperative Day #2

次要结局

  • Postoperative Length of Hospital Stay(Until patient's day of hospital discharge or a maximum of one month from cesarean delivery)
  • Postoperative Pain Medication Requirement(Until patient's day of hospital discharge or a maximum of one month from cesarean delivery)
  • Breastfeeding Initiation(Until patient's day of hospital discharge or a maximum of one month from cesarean delivery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter S. Bernstein

Principal Investigator

Montefiore Medical Center

研究点 (1)

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