Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-01-01 @ 1:26 PM
Study NCT ID:
NCT06473935
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maternal Well-being in the Perinatal Period
Sponsor:
IRCCS San Raffaele
Organization:
Study Overview
Official Title:
Maternal Well-being in the Perinatal Period: a Prospective Observational Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: