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Maternal Well-being in the Perinatal Period

S

San Donato Group (GSD)

Status

Enrolling

Conditions

Perinatal Depression
Mother-Child Relations
Loneliness
Anxiety

Treatments

Other: Questionnaires and focus groups

Study type

Observational

Funder types

Other

Identifiers

NCT06473935
Benessere Materno23

Details and patient eligibility

About

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.

Full 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.

Enrollment

134 estimated patients

Sex

Female

Volunteers

No Healthy Volunteers

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)

Trial design

134 participants in 1 patient group

Women during pregnancy and postpartum
Description:
Women during the last trimester of gestation (28th-35th week of gestation) and during the 18 months following the child's birth
Treatment:
Other: Questionnaires and focus groups

Trial contacts and locations

1

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Central trial contact

Valentina Di Mattei, Professor

Data sourced from clinicaltrials.gov

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