Maternal Well-being in the Perinatal Period: a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Loneliness
研究概览
简要总结
The goal of this observation study is to investigate the mental health status of women experiencing their first pregnancy, with particular attention to anxiety and depression symptoms, feelings of loneliness, and the quality of defense mechanisms employed.
详细描述
The primary goal of this observational study si to investigate the mental health status of women experiencing their first pregnancy, with particular attention to manifestations of anxiety and depression, feelings of loneliness, and the quality of defense mechanisms employed, during the last trimester of gestation (28th-35th week of gestation) and over the course of the 18 months following the child's birth.
Furthermore, the study aims to conduct an in-depth analysis of the variables associated with the psychological adaptation of women during the perinatal period, with particular reference to the following exploratory objectives:
- To explore the association between the investigated psychological dimensions and the quality of the bond with the child in the prenatal and postnatal periods.
- To identify any significant differences in the variables of interest between women who conceived naturally and those who underwent assisted reproductive technology (ART).
- To detect, through qualitative methods (semi-structured interviews and focus groups), the unmet needs of women during the perinatal period, as well as their preferences and expectations regarding the nature of desirable support interventions during this period. This would enable the construction and provision of an intervention model that closely aligns with the specific needs of this patient population.
The collected data will allow for the identification of individuals at higher risk of psychological distress and adaptation problems during the perinatal period, as well as potential impairment in the quality of the attachment bond with the child.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Adequate understanding of the Italian language
- •Willingness to participate in the study, expressed through the signing of the information sheet, consent declaration, and privacy statement
- •Women experiencing their first pregnancy
- •Women in the last trimester of gestation (28th-35th week of gestation) who will be followed for 18 months after childbirth
排除标准
- •Age under 18 years old
- •Women who are not able to understand the Italian language
- •Absence of the willingness to participate in the study, expressed through the signing of the information sheet, consent declaration, and privacy statement
- •Women who are not experiencing their first pregnancy
- •Women who are not in the last trimester of gestation (28th-35th week of gestation)
结局指标
主要结局
Loneliness
时间窗: June 1, 2024 - December 31, 2025
Feelings of loneliness during and after pregnancy
Depression
时间窗: June 1, 2024 - December 31, 2025
Levels of perinatal depression and of pregnancy-related anxiety
Anxiety
时间窗: June 1, 2024 - December 31, 2025
Levels of state and trait anxiety
Defense mechanisms
时间窗: June 1, 2024 - December 31, 2025
Nature of defense mechanisms during and after pregnancy
次要结局
- Attachment bond(June 1, 2024 - December 31, 2025)
- Unmet needs of women(June 1, 2024 - December 31, 2025)
- Women subjective experience(June 1, 2024 - December 31, 2025)
研究者
Valentina Di Mattei
Professor
IRCCS San Raffaele
