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Maternal Well-being in the Perinatal Period

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06473935
Enrollment
134
Registered
2024-06-25
Start date
2024-06-01
Completion date
2025-12-31
Last updated
2024-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Loneliness, Mother-Child Relations, Perinatal Depression

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.

Interventions

OTHERQuestionnaires 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.

Sponsors

IRCCS San Raffaele
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE

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)

Design outcomes

Primary

MeasureTime frameDescription
DepressionJune 1, 2024 - December 31, 2025Levels of perinatal depression and of pregnancy-related anxiety
AnxietyJune 1, 2024 - December 31, 2025Levels of state and trait anxiety
LonelinessJune 1, 2024 - December 31, 2025Feelings of loneliness during and after pregnancy
Defense mechanismsJune 1, 2024 - December 31, 2025Nature of defense mechanisms during and after pregnancy

Secondary

MeasureTime frameDescription
Women subjective experienceJune 1, 2024 - December 31, 2025Subjective experience of pregnancy and postpartum
Unmet needs of womenJune 1, 2024 - December 31, 2025Unmet needs of women during the perinatal period
Attachment bondJune 1, 2024 - December 31, 2025Quality of prenatal of attachment bond and in the postpartum period

Countries

Italy

Contacts

Primary ContactValentina Di Mattei, Professor
dimattei.valentina@hsr.it0226435829

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026