NCT06473935

Maternal Well-being in the Perinatal Period

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 134 (estimated)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: —

Summary

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.

Detailed description

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.

Conditions

• Perinatal Depression
• Anxiety
• Loneliness
• Mother-Child Relations

Interventions

Type	Name	Description
OTHER	Questionnaires and focus groups	Participation in the research involves completing a test battery composed of self-administered questionnaires, all validated in the Italian language. Additionally, qualitative data will be collected through semi-structured interviews (conducted in person or online, based on individual preferences) and focus groups, both lasting between 90 and 120 minutes.

Timeline

• Start date: 2024-06-01
• Primary completion: 2024-09-15
• Completion: 2025-12-31
• First posted: 2024-06-25
• Last updated: 2024-06-25

Locations

1 site across 1 country: Italy