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临床试验/NCT06322771
NCT06322771已完成不适用

Women's Refusal to Participate in a Randomized Trial Involving First-trimester Screening for Pre-eclampsia: Factors Associated With Refusal and Reasons for Acceptance and Refusal

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 472 人开始时间: 2024年4月11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
472
试验地点
1
主要终点
Factors associated with women's refusal

研究概览

简要总结

The main objective is to assess whether there are factors associated with women's refusal to participate in a randomized clinical trial involving first-trimester screening for pre-eclampsia. The secondary objective is to qualitatively evaluate the reasons for acceptance and refusal to participate.

详细描述

  1. Determine the acceptance/refusal rate among all women identified, eligible and offered RCT.
  2. Comparison of demographic characteristics between the two groups
  • Group 1: women accepting to participate in RCT
  • Group 2: women refusing to participate in RCT
  1. Assessment of motivations for acceptance (based on questionnaire given to women who agree to participate)
  2. Evaluation of reasons for refusal to participate - obstacles (based on the questionnaire given to women who refuse to participate).

研究设计

研究类型
Observational
观察模型
Cohort
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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Factors associated with women's refusal

时间窗: Day 1

The primary objective is to assess whether there are factors associated with women's refusal to participate in the RANSPRE randomized clinical trial.

次要结局

  • Questionnaire "refusal"(Day 1)
  • Number of refusals(Day 1)
  • Demographic characteristics(Day 1)
  • Number of acceptations(Day 1)
  • Questionnaire "acceptance"(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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