Unveiling Maternal-fetal BRAin-body Interactions in Pregnant WOmen Affected by Depression
NCT07932093, Not applicable, Recruiting, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Unveiling Maternal-fetal BRAin-body Interactions in Pregnant WOmen Affected by Depression | ClinicalTrials.gov |
| NCT number | NCT07932093 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 720 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | ClinicalTrials.gov |
| Conditions | Depression in Pregnancy, Major Depressive Disorder, Pregnancy | ClinicalTrials.gov |
| Interventions | Multimodal MRI and EEG-ECG/PPG recordings, Biological sampling, Clinical and neurodevelopmental assessments | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Prevalence of Major Depressive Disorder Among Screened Pregnant Women | At screening (within 20 gestational weeks) | Percentage of pregnant women screened within 20 gestational weeks who meet DSM-5 criteria for major depressive disorder according to the Structured Clinical Interview for DSM-5, Clinical Version (SCID-5-CV). The prevalence will be reported with its 95% confidence interval. | ClinicalTrials.gov |
| Secondary | Left Hippocampal Volume | At Visit 1 (by 22 gestational weeks) | Left hippocampal volume, expressed in milliliters (mL), estimated from 3D T1-weighted brain MRI processed with CAT12, compared between pregnant women with major depressive disorder and pregnant women without depression. | ClinicalTrials.gov |
| Secondary | Right Hippocampal Volume | At Visit 1 (by 22 gestational weeks) | Right hippocampal volume, expressed in milliliters (mL), estimated from 3D T1-weighted brain MRI processed with CAT12, compared between pregnant women with major depressive disorder and pregnant women without depression. | ClinicalTrials.gov |
| Secondary | Hamilton Depression Rating Scale (HDRS) Total Score at 6 Months Postpartum | 6 months postpartum | Maternal depressive symptom severity assessed with the clinician-administered Hamilton Depression Rating Scale (HDRS). Higher scores indicate more severe depression. | ClinicalTrials.gov |
| Secondary | Number of Depressive Relapses After Birth | From birth to 6 months postpartum | Number of depressive relapses per participant in the 6 months after birth, confirmed with the SCID-5-CV by a psychiatrist or psychologist. | ClinicalTrials.gov |
| Secondary | Bayley-III Cognitive Composite Score | 6 months of age | Infant cognitive development assessed with the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), cognitive scale. Composite scores have a mean of 100 and a standard deviation of 15; higher scores indicate better development. | ClinicalTrials.gov |
| Secondary | Bayley-III Language Composite Score | 6 months of age | Infant language development (receptive and expressive) assessed with the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), language scale. Composite scores have a mean of 100 and a standard deviation of 15; higher scores indicate better development. | ClinicalTrials.gov |
| Secondary | Bayley-III Motor Composite Score | 6 months of age | Infant motor development (fine and gross) assessed with the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), motor scale. Composite scores have a mean of 100 and a standard deviation of 15; higher scores indicate better development. | ClinicalTrials.gov |
| Other | Number of Participants With Preterm Birth | At birth | Number of participants delivering at 28 weeks or more but before 37 completed weeks of gestation. | ClinicalTrials.gov |
| Other | Number of Newborns With Low Birth Weight | At birth | Number of newborns with birth weight below 2500 grams. | ClinicalTrials.gov |
| Other | Number of Newborns Small for Gestational Age | At birth | Number of newborns classified as small for gestational age (SGA) based on birth weight for gestational age. | ClinicalTrials.gov |
| Other | Number of Newborns With Apgar Score Below 7 | 1 and 5 minutes after birth | Number of newborns with an Apgar score below 7 at 1 and at 5 minutes after delivery. The Apgar score ranges from 0 to 10, with lower scores indicating poorer condition at birth. | ClinicalTrials.gov |
| Other | Hammersmith Neonatal Neurological Examination (HNNE) Total Score | Within the first days after birth | Neonatal neurological maturity assessed with the Hammersmith Neonatal Neurological Examination (posture, tone, reflexes, movements, abnormal signs and behavior). Higher scores indicate more optimal neurological status. | ClinicalTrials.gov |
| Other | Edinburgh Postnatal Depression Scale (EPDS) Total Score | 1 month and 6 months postpartum | Maternal self-reported depressive symptoms assessed with the 10-item Edinburgh Postnatal Depression Scale. Total score ranges from 0 to 30; higher scores indicate more severe symptoms. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)