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

Last updated: July 10, 2023
Sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli
Overall Status: Active - Recruiting

Phase

N/A

Condition

Post-partum Depression

Depression

Treatment

Smartphone app

Blood and saliva collection

Psychometric scales

Clinical Study ID

NCT05951738
PRESeNT
1749118
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pregnant women of a singleton pregnancy
  • Age ≥ 18 years

Exclusion

Exclusion Criteria:

  • Uterine anomalies and obstetric complications
  • Comorbidity with severe or chronic diseases
  • Substance abuse
  • Language barrier

Study Design

Total Participants: 240
Treatment Group(s): 3
Primary Treatment: Smartphone app
Phase:
Study Start date:
February 11, 2022
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • IRCCS Centro San Giovanni di Dio Fatebenefratelli

    Brescia, 25125
    Italy

    Site Not Available

  • Centro Psiche Donna - Ospedale Macedonio Melloni - ASST Fatebenefratelli Sacco

    Milano,
    Italy

    Site Not Available

  • Ospedale San Raffaele

    Milano,
    Italy

    Site Not Available

  • ASST Bergamo ovest

    Treviglio,
    Italy

    Active - Recruiting

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