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临床试验/NCT03528655
NCT03528655已完成不适用

Influence of Decision Aids on the Choice of Mother-infant Rooming-in or Separation Care for Pregnant Women : a Randomized Controlled Trial

Taipei Medical University Shuang Ho Hospital2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2018年8月15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
150
试验地点
2
主要终点
Decision conflicts

研究概览

简要总结

During early postpartum period, mother-infant proximity is important for breastfeeding success. Rooming-in and separate care are both traditional practices. Rooming-in involves keeping the mother and the baby together in the same room after birth during hospitalization, whereas separate care keeps the baby in the hospital baby room. Shared decision making with decision aid (DA) is a way to provide information to pregnant women and to involve them in making decisions about their strategy on baby care. We have developed a DA to be administered during consultation for pregnant women, and conducted a randomized controlled trial (RCT) to evaluate the benefit of DA on decision making. The measurements include a battery of interview-based questionnaires and evaluations of decision regret. We expect the DA would benefit the intervention group in the aspects of knowledge and communication in choosing mother-baby care options.

详细描述

Background:

During early postpartum period, mother-infant proximity is important for breastfeeding success. Rooming-in and separate care are both traditional practices. Rooming-in involves keeping the mother and the baby together in the same room after birth during hospitalization, whereas separate care keeps the baby in the hospital baby room. Using decision aid (DA) is one way to provide information to pregnant women and to involve them in making decisions about their mother-baby care approaches.

Patients and Methods:

Decision aids are interventions designed to help pregnant women to choose their options of mother-baby care by providing information on those options and any potential outcome relevant to different mother-baby care options. Pregnant women considering mother-baby care approaches are randomly assigned to receive a DA or the standard oral information (control condition) during consultation.

By asking the pregnant women to look into a series of paired-comparisons, the DA leads the pregnant women to consider the competing attributes (i.e. specific risks/benefits) of the care options. The primary outcomes are decision conflicts and decision-making difficulties after consultation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women delivered by cesarean section or induction between 37 weeks, 0 days and 41 weeks, six days.

排除标准

  • Pregnant women with preeclampsia, mental disorder, do not understand Chinese, and newborn baby with infection, or not suitable for rooming-in care.

结局指标

主要结局

Decision conflicts

时间窗: An average of 3 days after delivering

Total score of decisional conflict scale

次要结局

  • Decision regret(An average of 3 days after delivering)

研究者

发起方
Taipei Medical University Shuang Ho Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ka-Wai Tam

Director of Shared Decision Making Resource Center

Taipei Medical University Shuang Ho Hospital

研究点 (2)

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