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| ID | Type | Description | Link |
|---|---|---|---|
| 1749118 | Other Grant/Funding Number | FRRB - Fondazione Regionale per la Ricerca Biomedica |
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The study aims at identifying:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Depressed | Other |
| |
| At high risk | Other |
| |
| Control | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood and saliva collection | Procedure | Blood and saliva samples from pregnant women; saliva samples from babies. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Differentially expressed genes and biological pathways modulation | 25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annamaria Cattaneo | Contact | +390303501361 | acattaneo@fatebenefratelli.eu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Centro San Giovanni di Dio Fatebenefratelli | Active, not recruiting | Brescia | 25125 | Italy | ||
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| Psychometric scales | Behavioral | A battery of psychometric scales and questionnaires. |
|
| Smartphone app | Other | A smartphone application has been developed in the context of the study as a potential preventive and screening strategy. |
|
| Immune-related factors 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 |
| Centro Psiche Donna - Ospedale Macedonio Melloni - ASST Fatebenefratelli Sacco |
| Not yet recruiting |
| Milan |
| Italy |
|
| Ospedale San Raffaele | Not yet recruiting | Milan | Italy |
|
| ASST Bergamo ovest | Recruiting | Treviglio | Italy |
|
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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