跳至主要内容
临床试验/NCT03883971
NCT03883971已完成不适用

Effects of 3D Printing Technology on Maternal Fetal Bonding Compared to 2D/3D Ultrasounds

Creighton University2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2018年5月1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
入组人数
96
试验地点
2
主要终点
Maternal Antenatal Attachment Scale (MAAS)

研究概览

简要总结

This study will invite healthy women with singleton pregnancies and normal 20 week ultrasounds to participate in the study that will involve completing a demographic questionnaire and measure of attachment, a 3D ultrasound, being randomized to receive a 3D printed model of the fetal face or not, and completing the attachment measure again.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
19 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • between19-45 years of age
  • singleton pregnancy
  • no less than 26-weeks pregnant and no more than 31-weeks pregnant at randomization
  • normal fetal anatomic survey (fas) ultrasound
  • fluent in English

排除标准

  • additional medical or entertainment ultrasounds after the 20 week anatomic ultrasound

研究组 & 干预措施

3D model

Experimental

patient is given 3D printed model of her fetus's face

干预措施: 3D printed model (Other)

picture

Placebo Comparator

patient is given a fetal picture only.

干预措施: Placebo (Other)

结局指标

主要结局

Maternal Antenatal Attachment Scale (MAAS)

时间窗: 5 minutes

The MAAS is a 19 item questionnaire measuring maternal-fetal attachment. Each item has five answer choices scored from 1 low attachment to 5 high attachment such that the total score ranges from 19 to 95. The measure also includes two subscales: (1) Quality of Attachment has 10 items with a range of 10-50 and measures the quality of the mother's attachment to her fetus. (2) Time measures the time spent in attachment mode (or intensity of preoccupation) and consists of 8 items for a range of 8 to 40. (for clarity one item included in the total score is not included in either subscale.)

次要结局

未报告次要终点

研究者

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

Amy Badura Brack

Professor

Creighton University

研究点 (2)

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