跳至主要内容
临床试验/NCT06473935
NCT06473935招募中不适用

Maternal Well-being in the Perinatal Period: a Prospective Observational Study

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2024年6月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Valentina Di Mattei

Professor

IRCCS San Raffaele

研究点 (1)

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