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临床试验/NCT03349151
NCT03349151已完成不适用

Postoperative Results of Early Versus On-demand Maternal Feeding After Cesarean Delivery

Acibadem University2 个研究点 分布在 1 个国家目标入组 262 人开始时间: 2017年11月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
262
试验地点
2
主要终点
Patient satisfaction

研究概览

简要总结

To compare early versus on demand maternal feeding after cesarean delivery regarding gastrointestinal complaints and patient's satisfaction.

详细描述

Two hundred uncomplicated singleton term pregnancies who had caesarean section under regional anaesthesia will be included in our trial. Patients will be randomized to a soft food diet (honey, skimmed cheese, soup, mashed potatoe, pudding, grissini) served on postoperative 2nd hour or whenever they wanted to eat on return to the ward. Thirty minutes after they eat their meal, nausea, vomiting, ileus and distention will be questioned. Participants will be provided with the visual analogue scale (VAS), which will be presented with a statement explaining what was intended to measure. Patient satisfaction before discharge from hospital will be recorded by the patient by using a 100-mm VAS (0= minimum satisfaction, 100= maximum satisfaction). Time to first flatus passage and defecation will be recorded after the caesarean section.

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
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • Uncomplicated singleton term pregnancy
  • Planned or intrapartum uncomplicated cesarean section
  • Cesarean section under regional anesthesia

排除标准

  • General anesthesia
  • History of bowel surgery
  • Prenatal diagnosis of fetal anomaly
  • Maternal disease
  • Intraoperative or immediate postoperative major complications

研究组 & 干预措施

Early feeding

Active Comparator

This group will be served soft meal diet served on postoperative 2nd hour on return to the ward.

干预措施: Early feeding (Behavioral)

On- demand feeding

Placebo Comparator

This group will be served soft meal diet served whenever they wanted to eat on return to the ward.

干预措施: On- Demand feeding (Behavioral)

结局指标

主要结局

Patient satisfaction

时间窗: On postoperative day 2 before they are discharged from the hospital.

The primary outcome is patient satisfaction before discharge from hospital, measured using a scale called visual analogue scale (VAS). It is a 100-mm long scale with adjectival descriptions at both end positions. There will be a statement explaining what was intended to measure. Participants will be asked to mark the VAS on the second they of the surgery before they are discharged from the hospital. On this scale 0= lack of satisfaction from the timing of having their meal after the surgery 100= full satisfaction from the timing of their meal after the surgery.

次要结局

  • Postoperative passage of flatus and defecation(Postoperative day 0 to day 2.)
  • Postoperative gastrointestinal complaints(Thirty minutes after the surgery)
  • Postoperative pain medication(Postoperative from day 0 to day 2)

研究者

发起方
Acibadem University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Esra Ozbasli

Instructor

Acibadem University

研究点 (2)

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