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临床试验/NCT02586428
NCT02586428终止不适用

Decision-Making in Patients Regarding Noninvasive Prenatal Testing

St. Louis University1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
33
试验地点
1
主要终点
will measure what percentages of patients elect noninvasive prenatal testing (NIPT), amniocentesis, or no testing before and after genetic counseling

研究概览

简要总结

Before and after a patient receives genetic counseling they will be offered the chance to complete the survey, by their counselor. Since each patient sees only one genetic counselor that counselor will be responsible for consenting and giving and collecting the finish surveys. No identifiers will be used. The investigators will emphasize that their answers will remain anonymous throughout the entire process, and that their participation is strictly voluntary. The patient will be provided with a survey and asked to complete this before their genetic counseling session and after.The survey will be returned to the genetic counselor and placed in a locked drawer. Information will also be collected from the medical record including age, pregnancy history and the reason for the visit.

详细描述

Patients who have abnormal ultrasound findings,advanced maternal age, abnormal serum biochemical screening, or a personal or family history of chromosomal/genetic conditions will be eligible for this study. Prior to receiving genetic counseling, the genetic counselor or her designee will approach the patient asking if she would be willing to participate in a survey that helps us better determine how well patients understand their testing options for the above issues.

The survey consists of two parts. The first part will be taken prior to genetic counseling to see what the patient's baseline understanding of their options are (this is study related.) If the patient agrees to participate in the study, she will then receive the first part of the survey. After completion of the first part of the survey, the patient will then receive genetic counseling (this is standard of care.). Information will also be collected from the medical record including age, pregnancy history and the reason for the visit. After receiving genetic counseling for their specific indication, patients will decide if they want noninvasive prenatal testing, amniocentesis, testing depending what their ultrasound shows, or no testing. After this the patient will be given the second part of the survey to complete (this is study related). Regardless of which testing is elected, (if any), participants are administered the same survey. After completing the survey, the patient will return the form to the genetic counselor or her designee. The recruitment period is expected to last approximately one year. After recruitment is completed, data analysis will take place. Interim data analysis make take place as well.

Patients will not be contacted for research purposes after the survey has been completed.

After patients complete this survey, they will require no further information. They are not being administered a treatment or receiving a direct benefit from participation; the study is designed only to obtain information about patient's decisions, knowledge, and attitudes regarding their testing options.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
14 Years 至 55 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • high risk pregnant women seen for genetic counseling

排除标准

  • not pregnant

结局指标

主要结局

will measure what percentages of patients elect noninvasive prenatal testing (NIPT), amniocentesis, or no testing before and after genetic counseling

时间窗: over the next 6 months

percentages of patient's choices

次要结局

  • will measure patients' reasons for electing or not electing testing(over the next 6 months)
  • Measure if patients' understand the different testing options.(over next 6 months)

研究者

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

fruhman@slu.edu

PI

St. Louis University

研究点 (1)

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