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Clinical Trials/NCT05951738
NCT05951738
Recruiting
Not Applicable

Exposures to PRenatal and Postnatal Adverse Stressful Experiences: Multimodal Omics Signatures Underlying Stress Vulnerability and Resilience and as Novel Targets for Preventive Strategies.

IRCCS Centro San Giovanni di Dio Fatebenefratelli4 sites in 1 country240 target enrollmentFebruary 11, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Perinatal Depression
Sponsor
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Enrollment
240
Locations
4
Primary Endpoint
Differentially expressed genes and biological pathways modulation
Status
Recruiting
Last Updated
2 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
February 11, 2022
End Date
July 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Responsible Party
Principal Investigator
Principal Investigator

Annamaria Cattaneo

Head of the Biological Psichiatry unit

IRCCS Centro San Giovanni di Dio Fatebenefratelli

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

Outcomes

Primary Outcomes

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 Outcomes

  • Rate and profile of DNA methylation(25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.)
  • Cortisol levels(25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.)
  • Smartphone app utility(From 25th of gestation to 12 months postpartum)
  • Immune-related factors levels(25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.)

Study Sites (4)

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