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临床试验/NCT02911727
NCT02911727已完成不适用

Fast-track Discharge After Elective Cesarean Section

Herning Hospital2 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2016年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
142
试验地点
2
主要终点
Parents' Postnatal Sense of Security

研究概览

简要总结

Cesarean section (CS) is a procedure with prolonged hospital stay compared to the routine for normal vaginal delivery in multiparas. The difference is caused mainly by postoperative pain but improvements in management of pain may change this situation and make early discharge possible. However, several aspects need to be considered.

The aim of this project is to evaluate fast-track discharge for multiparas after elective CS concerning neonatal and maternal complications as well as the parents' sense of security and well-being.

The study is a randomized controlled trial including 142 women allocated to either 1) the intention to discharge within 28 hours followed by a home visit or 2) standard discharge after at least 48 hours after elective CS.

This study will be among the first evaluating fast-track discharge after CS in a European context. If a positive outcome is achieved, we expect that fast-track discharge can be implemented with improved quality and reduced costs in postnatal care following elective CS.

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

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

入选标准

  • Planned elective CS of multiparous women
  • Singleton pregnancy
  • Gestational age at least 37+0 weeks
  • Prepregnancy BMI <35

排除标准

  • Lack of consent
  • Women with no or little understanding of and ability to speak Danish
  • Expected maternal or neonatal complications after delivery

结局指标

主要结局

Parents' Postnatal Sense of Security

时间窗: Measured one week after delivery

Using the validated PPSS-questionaire

次要结局

  • Breastfeeding(6 months after delivery)
  • Pain scores(During the first week postpartum)
  • Use of analgesia(During the first week postpartum)
  • Complications in the postnatal period(28 days postpartum)
  • Contacts to the health care system(28 days postpartum)
  • Mobilization(5 days postpartum)
  • Readmissions(28 days postpartum)
  • Surgical complications(28 days postpartum)

研究者

发起方
Herning Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne Kruse

MD

Herning Hospital

研究点 (2)

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