Actively Recruiting
Maternal Well-being in the Perinatal Period: a Prospective Observational Study
Led by IRCCS San Raffaele · Updated on 2024-06-25
134
Participants Needed
1
Research Sites
67 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the mental health of women experiencing their first pregnancy, focusing on symptoms of anxiety, depression, feelings of loneliness, and the quality of defense mechanisms used during the last trimester and up to 18 months after childbirth. The study aims to understand psychological adaptation in the perinatal period and explore links to the quality of the mother-child bond, differences between natural conception and assisted reproductive technology, and unmet needs through qualitative methods. Participants complete self-administered questionnaires validated in Italian and take part in semi-structured interviews or focus groups lasting 90 to 120 minutes, either in person or online. The research spans from the 28th to 35th week of pregnancy through the postpartum period, with data collection aimed at understanding psychological states and experiences in depth. Throughout the study, researchers assess depression, anxiety, loneliness, defense mechanisms, attachment bonds, women's subjective experiences, and unmet needs. The study runs from June 1, 2024, to December 31, 2025, and involves monitoring psychological health and adaptation over time to identify those at higher risk and to inform supportive interventions.
CONDITIONS
Brief Title
Maternal Well-being in the Perinatal Period
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or online) for eligibility assessment and consent
Duration - Up to 18 months following childbirth
Participants complete self-administered questionnaires and may participate in semi-structured interviews or focus groups to assess mental health and psychological adaptation during the last trimester of pregnancy and up to 18 months after childbirth.
Periodic questionnaire completions and 1 to 2 interviews or focus groups based on participant preference
Trial Site Locations
Total: 1 location
1
IRCCS San Raffaele
Milan, Italy, 20132
Actively Recruiting
Research Team
V
Valentina Di Mattei, Professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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