Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
134 participants
OBSERVATIONAL
2024-06-01
2025-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Women during pregnancy and postpartum
Women during the last trimester of gestation (28th-35th week of gestation) and during the 18 months following the child's birth
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
FEMALE
No
Sponsors
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IRCCS San Raffaele
OTHER
Responsible Party
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Valentina Di Mattei
Professor
Principal Investigators
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Valentina Di Mattei, Professor
Role: PRINCIPAL_INVESTIGATOR
IRCCS San Raffaele
Locations
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IRCCS San Raffaele
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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Valentina Di Mattei, Professor
Role: primary
Other Identifiers
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Benessere Materno23
Identifier Type: -
Identifier Source: org_study_id
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