Interest of a Short Early Psychological Care in Women With Miscarriage: a Controlled Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 932
- 主要终点
- anxiety
研究概览
简要总结
Miscarriage is a very common complication of pregnancy, accounting for 15.3% (95% CI 12.5-18.7%) of diagnosed pregnancies. Miscarriage would affect one in ten women during her lifetime. Worldwide, 23 million miscarriages occur annually.
Because of its frequency, miscarriage isoften considered as trivial event by caregivers. Still, miscarriage can be a traumatic event. Literature is consistent on the psychological morbidity associated with miscarriage. Anxiety, depression, post-traumatic stress have been studied in women after miscarriage. Cohort studies and clinical trials suggest that psychological and supportive interventions performed in women after miscarriage may improve women's psychological well-being and reduce miscarriage complications in subsequent pregnancies. However, to date, the literature is considered insufficient on the psychological care of women after a miscarriage.
详细描述
The aim of the study will be to evaluate the interest of a short early psychological care in women with miscarriage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 是
入选标准
- •women with an early miscarriage (defined by a spontaneous termination of pregnancy before the 14th week of amenorrhea)
- •women aged more than 18
- •women agreeing to participate in the study (signing the informed consent form).
排除标准
- •ectopic pregnancy
- •molar pregnancy
- •women with recurrent miscarriages
- •women less than 18
结局指标
主要结局
anxiety
时间窗: Month 3
Anxiety will be evaluated using the Scale Trait Anxiety Inventory version Y (STAI-Y-A). The STAI Form Y-A consists of a set of twenty item sonly focus on the psychological and not the somatic aspects of anxiety. The STAI Form Y-A is a self-reported questionnaire. Each item is scored from 1 to 4 and a sum score of all items is computed. Higher score indicates greater anxiety. Presence of anxiety will be defined by a score greater than or equal to 46.
次要结局
- depression(month 6)
- anxiety(month 6)