Exposures to Perinatal Adverse Experiences: Multimodal Omics Signature of Stress Vulnerability and Resilience and Preventive Strategies
NCT ID: NCT05951738
Last Updated: 2023-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
240 participants
INTERVENTIONAL
2022-02-11
2025-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
1. specific biological and molecular alterations associated with development of depression in pregnancy or risk of it.
2. 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;
3. 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Maternal Well-being in the Perinatal Period
NCT06473935
Risk Factors for Anxiety and Depression Among Pregnant Women During the COVID-19 Pandemic
NCT04377412
Poor Sleep During Pregnancy as Risk Factor for Post-partum Stress and Mental Health
NCT06379074
Evaluating the Effects of Stress in Pregnancy
NCT00525226
Screening for Depression and Anxiety in Pregnant and Postpartum Women: Evaluating Prevalence, Risk Factors, and the Stepped Screening Protocol in a Care Pathway
NCT06664593
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Depressed
Blood and saliva collection
Blood and saliva samples from pregnant women; saliva samples from babies.
Psychometric scales
A battery of psychometric scales and questionnaires.
Smartphone app
A smartphone application has been developed in the context of the study as a potential preventive and screening strategy.
At high risk
Blood and saliva collection
Blood and saliva samples from pregnant women; saliva samples from babies.
Psychometric scales
A battery of psychometric scales and questionnaires.
Smartphone app
A smartphone application has been developed in the context of the study as a potential preventive and screening strategy.
Control
Blood and saliva collection
Blood and saliva samples from pregnant women; saliva samples from babies.
Psychometric scales
A battery of psychometric scales and questionnaires.
Smartphone app
A smartphone application has been developed in the context of the study as a potential preventive and screening strategy.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Blood and saliva collection
Blood and saliva samples from pregnant women; saliva samples from babies.
Psychometric scales
A battery of psychometric scales and questionnaires.
Smartphone app
A smartphone application has been developed in the context of the study as a potential preventive and screening strategy.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age ≥ 18 years
Exclusion Criteria
* Comorbidity with severe or chronic diseases
* Substance abuse
* Language barrier
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
IRCCS Centro San Giovanni di Dio Fatebenefratelli
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Annamaria Cattaneo
Head of the Biological Psichiatry unit
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Brescia, , Italy
Centro Psiche Donna - Ospedale Macedonio Melloni - ASST Fatebenefratelli Sacco
Milan, , Italy
Ospedale San Raffaele
Milan, , Italy
ASST Bergamo ovest
Treviglio, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Roberta Anniverno
Role: primary
Francesco Benedetti
Role: primary
Marina Cattaneo
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1749118
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
PRESeNT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.