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临床试验/NCT03816423
NCT03816423已完成不适用

The Use of Videos for Informed Consent for Prenatal Genetic Screening: a Randomized Controlled Trial

University of South Florida2 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2019年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
106
试验地点
2
主要终点
Knowledge score change

研究概览

简要总结

This is a randomized controlled trial of a low income and low health literacy population of pregnant women from a diverse racial and ethnic background to assess the effectiveness of a pre-visit educational video on prenatal genetic screening and testing options.

详细描述

During pregnancy, women are routinely counseled about the risks of their offspring to have a chromosomal abnormality or birth defects. Both prenatal screening and diagnostic testing options to exclude aneuploidy should be offered to all pregnant women early in their pregnancy. A standardized educational video on prenatal screening may enhance a patient's understanding and knowledge of testing and support more informed decisions.

The objective of this study is to evaluate and compare patient knowledge scores on prenatal genetic screening before and after a standard prenatal care visit compared to the addition of a pre-appointment educational video.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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

  • pregnancy, english or spanish-speaking

排除标准

  • minors <18 years old,
  • > 21 completed weeks of gestational age,
  • prior genetic counseling during current pregnancy
  • fetus with known ultrasound abnormality

结局指标

主要结局

Knowledge score change

时间窗: same day for both groups

Compare the knowledge score change for both groups using the Maternal Serum Screening Knowledge Score Questionnaire" (MSSKQ)

Knowledge score

时间窗: same day for both groups

Evaluate the participants' baseline and post-visit knowledge scores on prenatal genetic screening for both groups using the "Maternal Serum Screening Knowledge Score Questionnaire" (MSSKQ)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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