Exposures to Perinatal Adverse Experiences: Multimodal Omics Signature of Stress Vulnerability and Resilience and Preventive Strategies (PRESeNT)
Primary Purpose
Perinatal Depression
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Blood and saliva collection
Psychometric scales
Smartphone app
Sponsored by
About this trial
This is an interventional screening trial for Perinatal Depression
Eligibility Criteria
Inclusion Criteria: Pregnant women of a singleton pregnancy Age ≥ 18 years Exclusion Criteria: Uterine anomalies and obstetric complications Comorbidity with severe or chronic diseases Substance abuse Language barrier
Sites / Locations
- IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Centro Psiche Donna - Ospedale Macedonio Melloni - ASST Fatebenefratelli Sacco
- Ospedale San Raffaele
- ASST Bergamo ovestRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Depressed
At high risk
Control
Arm Description
Outcomes
Primary Outcome Measures
Differentially expressed genes and biological pathways modulation
Secondary Outcome Measures
Rate and profile of DNA methylation
Cortisol levels
Immune-related factors levels
Smartphone app utility
Full Information
NCT ID
NCT05951738
First Posted
July 3, 2023
Last Updated
July 10, 2023
Sponsor
IRCCS Centro San Giovanni di Dio Fatebenefratelli
1. Study Identification
Unique Protocol Identification Number
NCT05951738
Brief Title
Exposures to Perinatal Adverse Experiences: Multimodal Omics Signature of Stress Vulnerability and Resilience and Preventive Strategies
Acronym
PRESeNT
Official Title
Exposures to PRenatal and Postnatal Adverse Stressful Experiences: Multimodal Omics Signatures Underlying Stress Vulnerability and Resilience and as Novel Targets for Preventive Strategies.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 11, 2022 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Centro San Giovanni di Dio Fatebenefratelli
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study aims at identifying:
specific biological and molecular alterations associated with development of depression in pregnancy or risk of it.
specific biological and molecular alterations due to exposure to maternal depression in utero that are still present in the offspring, that could possibly mediate the development of negative outcomes, and which are the possible clinical moderators of the associated risk;
whether antidepressant therapies prescribed by personal physician and the use of digital tools can have a preventive effect in the transmission of the risk from mothers to babies and in the development of depressive symptoms in high-risk pregnant women;
In order to achieve these, 80 pregnant women with depression, 80 at high-risk and 80 controls will be recruited and clinically monitored over pregnancy and postpartum along with their babies, specifically at these timepoints: 25th and 32nd weeks of gestation, 1 week postpartum, 4 weeks postpartum, 8 weeks postpartum, 12 months postpartum.
Women, based on their clinician choice, will receive antidepressants and will be provided with a smartphone app to monitor them, using a combination of personalised, daily self-reported assessments and sensors for passive data collection to cover mental and physical health.
Blood and saliva samples from pregnant women will be collected at the 25th and 32nd week of gestation to perform biological analyses.
Saliva samples from babies will be collected at 8 weeks and 12 months postpartum to perform biological analyses.
Clinical and psychological data will be collected from women at all timepoints.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perinatal Depression
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Depressed
Arm Type
Other
Arm Title
At high risk
Arm Type
Other
Arm Title
Control
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Blood and saliva collection
Intervention Description
Blood and saliva samples from pregnant women; saliva samples from babies.
Intervention Type
Behavioral
Intervention Name(s)
Psychometric scales
Intervention Description
A battery of psychometric scales and questionnaires.
Intervention Type
Other
Intervention Name(s)
Smartphone app
Intervention Description
A smartphone application has been developed in the context of the study as a potential preventive and screening strategy.
Primary Outcome Measure Information:
Title
Differentially expressed genes and biological pathways modulation
Time Frame
25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.
Secondary Outcome Measure Information:
Title
Rate and profile of DNA methylation
Time Frame
25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.
Title
Cortisol levels
Time Frame
25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.
Title
Immune-related factors levels
Time Frame
25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.
Title
Smartphone app utility
Time Frame
From 25th of gestation to 12 months postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pregnant women of a singleton pregnancy
Age ≥ 18 years
Exclusion Criteria:
Uterine anomalies and obstetric complications
Comorbidity with severe or chronic diseases
Substance abuse
Language barrier
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annamaria Cattaneo
Phone
+390303501361
Email
acattaneo@fatebenefratelli.eu
Facility Information:
Facility Name
IRCCS Centro San Giovanni di Dio Fatebenefratelli
City
Brescia
ZIP/Postal Code
25125
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Centro Psiche Donna - Ospedale Macedonio Melloni - ASST Fatebenefratelli Sacco
City
Milano
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberta Anniverno
Facility Name
Ospedale San Raffaele
City
Milano
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Benedetti
Facility Name
ASST Bergamo ovest
City
Treviglio
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marina Cattaneo
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Exposures to Perinatal Adverse Experiences: Multimodal Omics Signature of Stress Vulnerability and Resilience and Preventive Strategies
We'll reach out to this number within 24 hrs