Investigating mental health in first-time pregnant women
Maternal Well-being in the Perinatal Period: a Prospective Observational Study
This study looks at the mental health of first-time pregnant women during their last trimester and the year and a half after childbirth to see how they cope with feelings like anxiety and depression, and to understand their needs for support.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 134 (estimated) |
| Sex | Female |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06473935 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the mental health status of women experiencing their first pregnancy, focusing on anxiety, depression, loneliness, and defense mechanisms during the last trimester and the 18 months following childbirth. It will analyze the psychological adaptation of these women, exploring the bond with their child and differences between those who conceived naturally and through assisted reproductive technology. Additionally, qualitative methods such as interviews and focus groups will be employed to identify unmet needs and preferences for support interventions during the perinatal period.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older who are experiencing their first pregnancy and are in the last trimester of gestation.
Not a fit: Patients who are not first-time mothers or are not in the last trimester of pregnancy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved mental health support and interventions for first-time mothers during and after pregnancy.
How similar studies have performed: Other studies have shown success in exploring mental health during the perinatal period, making this approach relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Milan
- IRCCS San Raffaele — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Valentina Di Mattei, Professor — IRCCS San Raffaele
- Study coordinator: Valentina Di Mattei, Professor
- Email: dimattei.valentina@hsr.it
- Phone: 0226435829
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.