跳至主要内容
临床试验/NCT05123560
NCT05123560Unknown不适用

First-trimester Preeclampsia Screening: Women's Perspectives

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
750
试验地点
1
主要终点
Perception on information prior to the appointment to screen

研究概览

简要总结

The aim of this study is to evaluate women's perception on first-trimester preeclampsia screening as it is performed currently in daily practice. Thus, the investigators will assess the degree of satisfaction regarding the information received previously to the date of screening, and on the same day the screening is performed (at the time of first-trimester scan).

Women's unsderstanding regarding preeclampsia screening will be evaluated by means of an anonymous online questionnaire. Anxiety and stress related to the results will also be assessed.

详细描述

Preeclampsia screening was established in Catalonia in 2018. However, little training for professionals (doctors and midwifes) was performed. Women's opinion regarding screening was not asked prior to its implementation, and most women no dot receive any information prior to be screened.

Women's opinion on their pregnancy follow-ups is important, but this aspect is often not included in clinical practice policies. Thus, the objective of the study is to evaluate women's perception regarding current clinical practice in screening of preeclampsia, and their degree of satisfaction.

Screening and risk-assessments during pregnancy are also a potential cause of stress for women. Anxiety and stress regarding preeclampsia screening results will also be evaluated.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

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

  • Older that 18 years old
  • singleton pregnancy
  • low risc of cromosomal abnormalities (<1/1100)
  • normal first trimester ultrasound (no evidence of fetal malformations)

排除标准

  • Pacients will diagnosed mental disorders (including depression and anxiaety disorder)

结局指标

主要结局

Perception on information prior to the appointment to screen

时间窗: 11-14 weeks of pregnancy

Number of Participants with a high satisfaction degree with the received information prior to screening assessed by Baker's questionnaire. Answers to Baker's questionnaire: 1) Strongly agree 2) Somewhat agree 3) Neither agree nor disagree 4) Somewhat disagree 5) Strongly disagree. None of the answers mean a better or worse outcome. The aim is to record and characterize women's perception.

Perception on information received the day of the screening

时间窗: 11-14 weeks of pregnancy

Number of Participants with a high satisfaction degree with the received information the day of the screening assessed by Baker's questionnaire. Answers to Baker's questionnaire: 1) Strongly agree 2) Somewhat agree 3) Neither agree nor disagree 4) Somewhat disagree 5) Strongly disagree. None of the answers mean a better or worse outcome. The aim is to record and characterize women's perception.

次要结局

  • Anxiety and stress related to the results of the preeclampsia screening(11-14 weeks of pregnancy)

研究者

发起方
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cristina Trilla

Principal investigador

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

研究点 (1)

Loading locations...

相似试验