Maternal Well-being in the Perinatal Period

NCT06473935 | Recruiting

• 1 other identifier: Benessere Materno23
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Perinatal Depression; Anxiety; Loneliness; Mother-Child Relations

Outcome Measures

Primary Outcomes (4)

• Depression

  Levels of perinatal depression and of pregnancy-related anxiety

  June 1, 2024 - December 31, 2025

• Anxiety

  Levels of state and trait anxiety

  June 1, 2024 - December 31, 2025

• Loneliness

  Feelings of loneliness during and after pregnancy

  June 1, 2024 - December 31, 2025

• Defense mechanisms

  Nature of defense mechanisms during and after pregnancy

  June 1, 2024 - December 31, 2025

Secondary Outcomes (3)

• Attachment bond

  June 1, 2024 - December 31, 2025

• Women subjective experience

  June 1, 2024 - December 31, 2025

• Unmet needs of women

  June 1, 2024 - December 31, 2025

Study Arms (1)

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

Other: Questionnaires and focus groups

Interventions

Questionnaires and focus groups OTHER

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.

Women during pregnancy and postpartum

Eligibility Criteria

• Sex: female
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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 may not qualify if:

• 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)

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele

Milan, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Surveys and Questionnaires; Focus Groups

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Valentina Di Mattei, Professor

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valentina Di Mattei, Professor

CONTACT

0226435829; dimattei.valentina@hsr.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 25, 2024
• Study Start: June 1, 2024
• Primary Completion: September 15, 2024
• Study Completion: December 31, 2025
• Last Updated: June 25, 2024

Record last verified: 2024-06

Locations

IT (1)