Maternal Well-being in the Perinatal Period

Maternal Well-being in the Perinatal Period: a Prospective Observational Study

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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety; Loneliness; Mother-Child Relations; Perinatal Depression
• Intervention / Treatment: Other: Questionnaires and focus groups

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.

• Study Type: Observational
• Enrollment (Estimated): 134

Contacts and Locations

• Study Contact: Name: Valentina Di Mattei, Professor; Phone Number: 0226435829; Email: dimattei.valentina@hsr.it

Study Locations

• Italy
  • Milan, Italy, 20132
    • Recruiting
    • IRCCS San Raffaele
    • Contact: Valentina Di Mattei, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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).

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attachment bond	Quality of prenatal of attachment bond and in the postpartum period	June 1, 2024 - December 31, 2025
Women subjective experience	Subjective experience of pregnancy and postpartum	June 1, 2024 - December 31, 2025
Unmet needs of women	Unmet needs of women during the perinatal period	June 1, 2024 - December 31, 2025

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele
• Investigators: Principal Investigator: Valentina Di Mattei, Professor, IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): September 15, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 19, 2024
• First Submitted That Met QC Criteria: June 19, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: June 19, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: Benessere Materno23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No