Effects of 3D Ultrasonography and 3D Printed Images on Maternal-fetal Attachment and Its Correlation With Overall Smoking Within Pregnancy and Smoking Cessation
试验速览
- 阶段
- 不适用
- 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
To determine whether 3D models of fetus' face created from 3D ultrasound will increase maternal attachment and aid in smoking cessation. Half of participants will receive 3D model and half will receive a picture of 3D ultrasound of their baby
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
- 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
- 否
入选标准
- •Age - Female 19-45 years of age
- •Fluent in English
- •Currently smoking cigarettes
- •Currently pregnant (between 21- and 36-weeks' gestation)
- •Have normal 20-week ultrasound
排除标准
- •Having received more than 3 ultrasounds prior to study
- •Medical need for additional ultrasounds
- •Multiple fetuses
- •> 31 weeks gestation
- •Does not smoke cigarettes
- •Is not fluent in English
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.)
Salivary cotinine
时间窗: 5 minutes
Cotinine is a stable nicotine metabolite produced by the liver. This is to test amount mother has smoked.
The Timeline Follow Back (TLFB):
时间窗: 10 minutes
This semi-structured interview utilizes a calendar to aid in participants' recall of smoking throughout pregnancy. The TLFB method is the preferred approach to measure substance use and has shown reliability when used for pregnant women in previous studies
次要结局
未报告次要终点