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临床试验/NCT04229654
NCT04229654已完成不适用

Awareness, Expectations, and Perception of Anomaly Ultrasound Scan Among Pregnant Women in a Northern México Population

Hospital Universitario Dr. Jose E. Gonzalez1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2019年11月4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
400
试验地点
1
主要终点
Knowledge

研究概览

简要总结

To describe the knowledge, expectations, and perception of women towards the mid-trimester ultrasound scan to detect fetal anomalies in a Mexican population.

详细描述

A cross-sectional survey was conducted in two prenatal diagnostic centers located in Monterrey, Nuevo León, México. One was a university prenatal diagnostic center and the other a private one. The centers were purposively selected to represent different characteristics of the level of care and demographic characteristics. The research instrument was a 26-item questionnaire divided into three sections. The first section contained 12 questions designed to assess women's ideas about the purpose and limitations of the scan (yes/no). The second was on expectations before the scan while the third dealt on women´s perception of the fetus during the ultrasound examination. All women attending for a mid-trimester anomaly scan were invited to fill out the first two parts of a pretested structured questionnaire before the scan and after the ultrasound examination, the third part of the questionnaire concerning their experience of the scan session was completed and collected.

Additionally, the questionnaire included demographic questions (age, parity, educational level, marital status). The source of the questionnaire items was interviews with experts.

Ethical approval for this study was obtained from the Institutional review board. The anomaly scan was performed by fetal-maternal specialists between 18 and 24.6-week gestation.

All data were recorded and analyzed using the Statistical Package for the Social Sciences version 22.0 (SPSS Inc, Illinois, USA). Descriptive statistics were used for the sociodemographic data. Categorical variables were compared using the chi-square test or Fisher exact test. Univariate and multivariate regression analyses were performed to delineate the factors associated with a higher knowledge level. A p-value <0.05 was considered statistically significant.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

性别
Female
接受健康志愿者
是

入选标准

  • •Pregnant women between 18 and 24.6 weeks
  • •Exclusion Crireria:
  • •Time constraints
  • •Lack of interest
  • •Maternal blindness

排除标准

  • 未提供

结局指标

主要结局

Knowledge

时间窗: 10 minutes

Consisted of 12 items that asked about women´s to evaluate the background knowledge about the purpose and limitations of ultrasound anomaly scan. The first three items asked about the women's knowledge and worries about ultrasound and their understanding of the information provided for their attending physicians. The last 3 items were completed after the ultrasound examination, those items asked about opinions regarding the utility and relief of information provided. The correct answers from the other 6 items were summed to form a total score ranging from 0 to 6. The total scores were categorized into three groups: score 0-2 as poor, 3-4 as intermediate, and 5-6 as good.

Perception of the fetus

时间窗: 5 minutes

Consisted of 6 items that asked about women´s perception of the fetus during ultrasound examination. A yes/no style were used to measure this outcome.

Expectations

时间窗: 5 minutes

Consisted of 8 items that asked about women´s expectations before the ultrasound examination. A yes/no style were used to measure this outcome.

次要结局

  • Demographic characteristics(5 minutes)

研究者

发起方
Hospital Universitario Dr. Jose E. Gonzalez
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. med Flavio Hernández Castro

Principal investigator

Hospital Universitario Dr. Jose E. Gonzalez

研究点 (1)

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