Exposures to Perinatal Adverse Experiences: Multimodal Omics Signature of Stress Vulnerability and Resilience and Preventive Strategies (PRESeNT)

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Status: Enrolling

Conditions: Perinatal Depression

Treatments: Behavioral: Psychometric scales; Procedure: Blood and saliva collection; Other: Smartphone app

Study type: Interventional

Funder types: Other

Identifiers

NCT05951738

PRESeNT

1749118 (Other Grant/Funding Number)

Details and patient eligibility

About

The study aims at identifying:

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.

Enrollment: 240 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 3 patient groups

Depressed

Other group

Treatment:

Procedure: Blood and saliva collection

Other: Smartphone app

Behavioral: Psychometric scales

At high risk

Other group

Treatment:

Procedure: Blood and saliva collection

Other: Smartphone app

Behavioral: Psychometric scales

Control

Other group

Treatment:

Procedure: Blood and saliva collection

Other: Smartphone app

Behavioral: Psychometric scales