Clinical trial NCT05951738: Exposures to Perinatal Adverse Experiences: Multimodal Omics Signature of Stress Vulnerability and Resilience and Preventive Strategies
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
Overall status: RECRUITING
Phase: NA
Conditions: Perinatal Depression
Lead sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


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

Primary outcomes:
measure: Differentially expressed genes and biological pathways modulation
timeFrame: 25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.
Secondary outcomes:
measure: Rate and profile of DNA methylation
timeFrame: 25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.
measure: Cortisol levels
timeFrame: 25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.
measure: Immune-related factors levels
timeFrame: 25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.
measure: Smartphone app utility
timeFrame: From 25th of gestation to 12 months postpartum
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: IRCCS Centro San Giovanni di Dio Fatebenefratelli
city: Milano
country: Italy
facility: Centro Psiche Donna - Ospedale Macedonio Melloni - ASST Fatebenefratelli Sacco
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Treviglio
country: Italy
facility: ASST Bergamo ovest
Study officials:
References: