Identifying biological markers of stress vulnerability and resilience in pregnant women
Exposures to PRenatal and Postnatal Adverse Stressful Experiences: Multimodal Omics Signatures Underlying Stress Vulnerability and Resilience and as Novel Targets for Preventive Strategies.
NA · IRCCS Centro San Giovanni di Dio Fatebenefratelli · NCT05951738
This study is trying to find out how biological changes during pregnancy affect depression in mothers and their babies by looking at different groups of pregnant women, including those with depression and those who are healthy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | IRCCS Centro San Giovanni di Dio Fatebenefratelli (other) |
| Locations | 4 sites (Brescia and 3 other locations) |
| Trial ID | NCT05951738 on ClinicalTrials.gov |
What this trial studies
This study investigates the biological and molecular changes linked to perinatal depression and the impact of maternal depression on offspring. It aims to recruit 240 participants, including pregnant women with depression, those at high risk, and healthy controls, to monitor their health throughout pregnancy and postpartum. The study will utilize blood and saliva samples, psychometric assessments, and digital tools to evaluate the effectiveness of antidepressant therapies and preventive strategies. The goal is to understand how these factors contribute to the risk of depression in mothers and their babies.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 and older, either with depression, at high risk for depression, or healthy controls.
Not a fit: Patients with uterine anomalies, severe chronic diseases, substance abuse issues, or language barriers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved preventive strategies for perinatal depression, benefiting both mothers and their children.
How similar studies have performed: Other studies have shown promise in identifying biological markers for depression, but this specific approach combining multimodal omics and preventive strategies is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brescia and 3 other locations
- IRCCS Centro San Giovanni di Dio Fatebenefratelli — Brescia, Italy (ACTIVE_NOT_RECRUITING)
- Centro Psiche Donna - Ospedale Macedonio Melloni - ASST Fatebenefratelli Sacco — Milano, Italy (NOT_YET_RECRUITING)
- Ospedale San Raffaele — Milano, Italy (NOT_YET_RECRUITING)
- ASST Bergamo ovest — Treviglio, Italy (RECRUITING)
Study contacts
- Study coordinator: Annamaria Cattaneo
- Email: acattaneo@fatebenefratelli.eu
- Phone: +390303501361
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Perinatal Depression