Maternal Well-being in the Perinatal Period

Recruiting

• Conditions: Loneliness; Anxiety; Perinatal Depression; Mother-Child Relations
• Interventions: Other: Questionnaires and focus groups

• Registration Number: NCT06473935
• Lead Sponsor: IRCCS San Raffaele

Brief 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.

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-06-01
• Study First Submitted: 2024-06-19
• Study First Submitted QC: 2024-06-19
• Last Update Submitted: 2024-06-19
• Study First Posted: 2024-06-25
• Last Update Posted: 2024-06-25
• Primary Completion: 2024-09-15
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 134

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women during pregnancy and postpartum	Questionnaires and focus groups	Women during the last trimester of gestation (28th-35th week of gestation) and during the 18 months following the child's birth

Primary Outcome Measures

Name	Time	Method
Loneliness	June 1, 2024 - December 31, 2025	Feelings of loneliness during and after pregnancy
Depression	June 1, 2024 - December 31, 2025	Levels of perinatal depression and of pregnancy-related anxiety
Anxiety	June 1, 2024 - December 31, 2025	Levels of state and trait anxiety
Defense mechanisms	June 1, 2024 - December 31, 2025	Nature of defense mechanisms during and after pregnancy

Secondary Outcome Measures

Name	Time	Method
Attachment bond	June 1, 2024 - December 31, 2025	Quality of prenatal of attachment bond and in the postpartum period
Unmet needs of women	June 1, 2024 - December 31, 2025	Unmet needs of women during the perinatal period
Women subjective experience	June 1, 2024 - December 31, 2025	Subjective experience of pregnancy and postpartum

Trial Locations

Locations (1)

IRCCS San Raffaele; 🇮🇹 Milan, Italy