Refusal to Participate in a Randomized Trial Involving Pregnancy and Childbirth: Factors Associated With Refusal and Reasons for Refusal and Acceptance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 526
- 试验地点
- 4
- 主要终点
- Collection of obstetric characteristics
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 pregnancy and childbirth in France. The secondary objective is to qualitatively evaluate the reasons for acceptance and refusal to participate.
详细描述
- Determine the acceptance/refusal rate among all women identified, eligible and offered RCT.
- Comparison of demographic characteristics between the two groups
- Group 1: women accepting to participate in RCT
- Group 2: women refusing to participate in RCT
- Assessment of motivations for acceptance (based on questionnaire given to women who agree to participate)
- 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
- 否
入选标准
- •The study will be offered to all women who have been offered to participate in a randomized trial relating to their pregnancy and/or childbirth in participating services.
排除标准
- 未提供
研究组 & 干预措施
Acceptance
Women who accept to participate to a Randomized Controlled Trial (RCT)
干预措施: Questionnaire about acceptance (Behavioral)
Refusal
Women who refuse to participate to a Randomized Controlled Trial (RCT)
干预措施: Questionnaire about refusal (Behavioral)
结局指标
主要结局
Collection of obstetric characteristics
时间窗: Day 1
Parity, obstetric history (first-trimester pregnancy loss, IUFD, perinatal death), pregnancy complications, gestational age… The primary objective is to assess whether there are factors associated with women's refusal to participate in randomized clinical trials. No score, it is a qualitative analyse.
Collection of maternal demographic characteristics
时间窗: Day 1
Age, level of education, profession, geographic origin, health insurance/mutual, marital status The primary objective is to assess whether there are factors associated with women's refusal to participate in randomized clinical trials. No score, it is a qualitative analyse.
Collection of characteristics related to information provided
时间窗: Day 1
By whom? , with whom? (impact of the companion), when? The primary objective is to assess whether there are factors associated with women's refusal to participate in randomized clinical trials. No score, it is a qualitative analyse.
次要结局
- Motivation linked to acceptance(Day 1)
- Reason for refusing to participate(Day 1)