Utilization of Antidepressants During Pregnancy: a Multinational Cross-sectional, Web-based Survey - French Contribution
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 402
- 试验地点
- 1
- 主要终点
- evaluate an international scale for measuring adherence to antidepressants during pregnancy
研究概览
简要总结
Depression is one of the most common psychiatric disorders accompanying pregnancy and the postpartum period. In Western countries, it is estimated that up to 18% of women experience depression during pregnancy, and 13% have at least one episode of severe depression.
Although non-pharmacological interventions are of central importance in treating depression and anxiety, especially during pregnancy, for some women, pharmacological interventions are necessary.
While prescription data is inadequate to capture real-life adherence to medication, there is also a lack of suitable self-completed scales to measure adherence to antidepressants among pregnant women. The information the investigators currently have on adherence to antidepressants in pregnancy is from the studies that have used pregnancy non-specific measurements, which do not consider pregnancy-related factors that could influence adherence, including fear of the potential teratogenic risk of antidepressants or untreated psychiatric disorders to the fetus and specific pregnancy-related concerns, such as being a good mother and bonding with a child that is going to be born.
In this study, the investigators will develop and adherence scale dedicated to antidepressant treatement during pregnancy and investigators will include pregnancy-specific predictors of antidepressant adherence as well as the woman's beliefs and perceptions regarding such use.
The recruitment of the patients will be done in various countries from Europe. This protocol covers the French contribution to this international initiative
详细描述
Depression is one of the most common psychiatric disorders accompanying pregnancy and the postpartum period.
In Western countries, it is estimated that up to 18% of women experience depression during pregnancy, and 13% have at least one episode of severe depression. Anxiety disorders are also common in the perinatal period, with a prevalence estimate of 15%. In many cases, these disorders concur, adding substantial illness burden to the woman.
Although non-pharmacological interventions are of central importance in treating depression and anxiety, especially during pregnancy, for some women, pharmacological interventions are necessary.
Selective serotonin reuptake inhibitors (SSRIs) are in the first line of the pharmacological treatment of depression and anxiety, but depending on the clinical situation, the choice is often between SSRIs (international prevalence of use in pregnancy: 3.0% [95% CI 2.3-3.7]), serotonin-norepinephrine reuptake inhibitors (SNRIs; 0.7% [95% CI 0.5-0.9]) and tricyclic antidepressants (TCAs; 0.4% [95% CI 0.3-0.5]). Prevalence estimates have shown significant variation by geographical region, with a prevalence estimate of 1.6% for SSRIs in Europe.
When choosing treatment options for pregnant women, three crucial aspects must be considered: the benefits of the treatment, the risks of the treatment, and the risks of untreated disease for both mother and child.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 50 years
- •Pregnant or have given birth in the past year.
- •Used antidepressants 12 months before and/or during pregnancy
排除标准
- •Women under legal protection
结局指标
主要结局
evaluate an international scale for measuring adherence to antidepressants during pregnancy
时间窗: Through study time period, 6 months
evaluate an international scale for measuring adherence to antidepressants during pregnancy (Adherence to Antidepressants in Pregnancy Scale ; AADP)
develop an international scale for measuring adherence to antidepressants during pregnancy
时间窗: Through study time period, 6 months
develop an international scale for measuring adherence to antidepressants during pregnancy, building upon the scale previously piloted in a Norwegian population (Adherence to Antidepressants in Pregnancy Scale ; AADP)
次要结局
- estimate the prevalence of low antidepressant adherence, as well as associated maternal factors(Through study time period, 6 months)