Clinical trial NCT06473935: Maternal Well-being in the Perinatal Period
Official title: Maternal Well-being in the Perinatal Period: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Perinatal Depression
Anxiety
Loneliness
Mother-Child Relations
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 134
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We plan to recruit a sample of at least 134 patients. This sample size allows us to meet the recommendations obtained from conducting the power analysis.

The sample size calculation was performed using G\*Power software (version 3.1.9.6, Faul et al., 2007).

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Depression
timeFrame: June 1, 2024 - December 31, 2025
measure: Anxiety
timeFrame: June 1, 2024 - December 31, 2025
measure: Loneliness
timeFrame: June 1, 2024 - December 31, 2025
measure: Defense mechanisms
timeFrame: June 1, 2024 - December 31, 2025
Secondary outcomes:
measure: Attachment bond
timeFrame: June 1, 2024 - December 31, 2025
measure: Women subjective experience
timeFrame: June 1, 2024 - December 31, 2025
measure: Unmet needs of women
timeFrame: June 1, 2024 - December 31, 2025
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele
Study officials:
affiliation: IRCCS San Raffaele
name: Valentina Di Mattei, Professor
role: PRINCIPAL_INVESTIGATOR
References: