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Unveiling Maternal-fetal BRAin-body Interactions in Pregnant WOmen Affected by Depression (BRAWO)

6 november 2026 bijgewerkt door: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

The goal of this study is to learn how depression during pregnancy is linked to changes in the brain and body of the mother and to the development of the baby, in pregnant women with major depressive disorder (MDD) and pregnant women without depression.

The main questions it aims to answer are:

  • How common is major depressive disorder during pregnancy in a European multi-site cohort?
  • Do pregnant women with MDD show differences in hippocampal volume compared with pregnant women without depression?
  • Do maternal blood, placenta, cord blood, brain imaging and heart activity measures, and the brain and development of the babies, differ between the two groups?

Pregnant women will be screened within the 20th week of pregnancy and assigned to the MDD group or to the control group based on a structured clinical interview. They will not receive any study drug: women with depression will receive the usual care recommended by clinical guidelines.

Participants will:

  • Have clinical, psychiatric and psychological assessments (interviews and questionnaires) at screening, at 22, 26 and 32 weeks of pregnancy, at birth, and at 1 and 6 months after birth
  • Have a brain MRI with simultaneous EEG-ECG or photoplethysmography (PPG) at about 22 weeks of pregnancy
  • Have a fetal MRI by 22 weeks and fetal ultrasound scans at 22, 26 and 32 weeks
  • Give blood samples at 22, 26 and 32 weeks of pregnancy, and a cord blood sample at birth (placenta samples in a subgroup at the Milan center only)

Their newborns will have a neurological and visual examination, a brain MRI and an EEG-ECG or PPG recording after birth, and a developmental assessment (Bayley Scales) at 6 months.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

BRAWO is a non-pharmacological, international, multicenter, non-profit study conducted in Italy (Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, coordinating center), Spain (Institute of Biomedicine of Seville, IBiS) and Germany (Philipps University Marburg). It implements Work Package 3 of the BRAWO research project, funded under the ERA-NET NEURON Joint Transnational Call 2024 "Bidirectional brain-body interactions".

The study is classified as interventional because it includes procedures that are not part of standard clinical care (maternal, fetal and neonatal MRI, EEG-ECG/PPG recordings, biological sampling). These procedures are non-invasive or minimally invasive. No investigational medicinal product is tested; women with MDD receive standard care, which may include SSRI antidepressants.

Groups:

  • Group 1: pregnant women with MDD diagnosed with the SCID-5-CV at screening
  • Group 2: pregnant women without current or past psychiatric disorders
  • Newborns of enrolled women, enrolled at birth after consent from both parents

Visits: V0 screening (within 20 gestational weeks, GW), V1 (by 22 GW), V2 (26 GW), V3 (32 GW), V4 (birth), V5 (1 month postpartum), V6 (6 months postpartum).

Maternal clinical assessments include clinician-rated scales (Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, Global Assessment of Functioning) and self-rated questionnaires (EPDS, STAI Y1-2, SCL-90-R, CES-D); bonding, couple and family scales (MPAS, PBQ, ECR-R, RQI, DAS, FES, PSI-SF) are administered at 1 and 6 months postpartum.

Biological samples: maternal plasma at V1, V2 and V3, umbilical venous cord blood at birth, and placental tissue (elective cesarean deliveries, about 10 participants per group, Milan only). Proteomic analyses (LC-MS/MS) are centralized in Milan; placental samples also undergo RNA sequencing and histological analyses. With specific consent, residual samples are stored in the Policlinico biobank.

Neuroimaging and electrophysiology: maternal multimodal MRI (structural, diffusion, task and resting-state functional MRI) with simultaneous EEG-ECG (Milan) or ECG/PPG (Seville, Marburg); fetal MRI; neonatal MRI and EEG-ECG/PPG at 40+0 to 43+6 weeks of gestational age. Data are harmonized across sites (e.g., ComBat).

Sample size: a screening target of 600 pregnant women was calculated to estimate MDD prevalence (expected 15%, precision ±3.42%, 95% confidence level, 30% dropout). At least 60 women per group completing follow-up to 6 months postpartum provide >90% power to detect hippocampal volume differences (two-sample t-test, alpha 0.05). In total, 600 pregnant women and 120 newborns are expected to be enrolled. An interim analysis of dropout rate and data quality is planned at about half of enrollment.

Pre-collected data from a previous study at the coordinating center (MINI protocol) and publicly available data from the developing Human Connectome Project (dHCP) will be used to train multivariate, machine learning and dynamical systems models, which will be tested on BRAWO data to predict maternal and infant outcomes at 6 months.

Data are collected in REDCap and imaging data in XNAT.

Studietype

Ingrijpend

Inschrijving (Geschat)

720

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Duitsland
    • Hesse
      • Marburg, Hesse, Duitsland, 35039
        • Nog niet aan het werven
        • Department of Psychiatry and Psychotherapy, Philipps University Marburg
  • Italië
    • Lombardy
      • Milan, Lombardy, Italië, 20122
        • Werving
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Spanje
      • Seville, Spanje, 41013
        • Nog niet aan het werven
        • Instituto de Biomedicina de Sevilla (IBiS)

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Niet ouder dan 45 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

Pregnant women with major depressive disorder (Group 1):

  • Signed informed consent and ability to understand and provide it
  • Age between 18 and 45 years
  • IQ > 70 (4 subtests of WAIS-IV: Vocabulary, Similarities, Block Design, Matrix Reasoning)
  • Diagnosis of major depressive disorder according to the SCID-5-CV at screening (within 20 gestational weeks)

Pregnant women without depression (Group 2):

  • Signed informed consent and ability to understand and provide it
  • Age between 18 and 45 years
  • IQ > 70 (4 subtests of WAIS-IV: Vocabulary, Similarities, Block Design, Matrix Reasoning)
  • No current or past psychiatric disorders (SCID-5-CV)
  • No family history of psychiatric disorders (SCID-5-CV and FIGS)

Placental tissue sampling (Milan only, Groups 1 and 2):

  • Elective cesarean delivery
  • Absence of labor

Newborns:

  • Informed consent signed by both parents
  • Full-term birth (gestational age at birth of 37 weeks or more)

Exclusion Criteria:

Pregnant women (Groups 1 and 2):

  • History of head trauma with loss of consciousness
  • Neurological or degenerative disorders
  • Comorbid psychiatric disorders
  • Twin pregnancy
  • Pregnancy resulting from assisted reproductive technology with egg donation
  • History of perinatal alcohol or drug abuse
  • Infectious or autoimmune diseases
  • Use of systemic corticosteroids
  • Congenital, genetic or neurological disorders affecting the mother or the fetus
  • Body mass index (BMI) > 30
  • Severe prior obstetric conditions
  • Absolute or relative contraindications to MRI

Newborns:

  • Congenital, genetic or neurological disorder of the newborn

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: Pregnant Women With Major Depressive Disorder (Group 1)

Pregnant women aged 18-45 years diagnosed with major depressive disorder (SCID-5-CV) at screening (within 20 gestational weeks), followed until 6 months postpartum, and their newborns. Participants receive standard clinical care for depression, which may include SSRI antidepressants; no study drug is administered.
Diagnostische toets: Multimodal MRI and EEG-ECG/PPG recordings

Study-specific, non-invasive acquisitions: maternal brain MRI (structural, diffusion, task and resting-state fMRI) with simultaneous EEG-ECG (Milan) or ECG/PPG (Seville, Marburg) by 22 gestational weeks; fetal MRI by 22 gestational weeks; fetal ultrasound at 22, 26 and 32 gestational weeks; neonatal brain MRI and polygraphic EEG-ECG (Milan, Marburg) or MRI with PPG (Seville, Marburg) at 40+0 to 43+6 weeks of gestational age, during spontaneous sleep without sedation.

Procedure: Biological sampling

Maternal peripheral blood sampling at 22, 26 and 32 gestational weeks (plasma aliquots stored at -80 °C); umbilical venous cord blood sampling at birth; placental tissue sampling in a subgroup of about 10 participants per group with elective cesarean delivery (Milan only). Proteomic analysis by LC-MS/MS; placental RNA sequencing and histology. Residual samples stored in the Policlinico biobank with specific consent.

Ander: Clinical and neurodevelopmental assessments

Maternal clinician-rated scales (HDRS, HARS, GAF) and self-rated questionnaires (EPDS, STAI Y1-2, SCL-90-R, CES-D) from screening to 6 months postpartum; bonding, couple and family scales (MPAS, PBQ, ECR-R, RQI, DAS, FES, PSI-SF) at 1 and 6 months postpartum; neonatal Hammersmith Neonatal Neurological Examination and visual function assessment after birth; Bayley Scales of Infant and Toddler Development, Third Edition at 6 months.
Ander: Pregnant Women Without Depression (Group 2)

Pregnant women aged 18-45 years without current or past psychiatric disorders and without family history of psychiatric disorders (SCID-5-CV and FIGS), followed until 6 months postpartum, and their newborns.
Diagnostische toets: Multimodal MRI and EEG-ECG/PPG recordings

Study-specific, non-invasive acquisitions: maternal brain MRI (structural, diffusion, task and resting-state fMRI) with simultaneous EEG-ECG (Milan) or ECG/PPG (Seville, Marburg) by 22 gestational weeks; fetal MRI by 22 gestational weeks; fetal ultrasound at 22, 26 and 32 gestational weeks; neonatal brain MRI and polygraphic EEG-ECG (Milan, Marburg) or MRI with PPG (Seville, Marburg) at 40+0 to 43+6 weeks of gestational age, during spontaneous sleep without sedation.

Procedure: Biological sampling

Maternal peripheral blood sampling at 22, 26 and 32 gestational weeks (plasma aliquots stored at -80 °C); umbilical venous cord blood sampling at birth; placental tissue sampling in a subgroup of about 10 participants per group with elective cesarean delivery (Milan only). Proteomic analysis by LC-MS/MS; placental RNA sequencing and histology. Residual samples stored in the Policlinico biobank with specific consent.

Ander: Clinical and neurodevelopmental assessments

Maternal clinician-rated scales (HDRS, HARS, GAF) and self-rated questionnaires (EPDS, STAI Y1-2, SCL-90-R, CES-D) from screening to 6 months postpartum; bonding, couple and family scales (MPAS, PBQ, ECR-R, RQI, DAS, FES, PSI-SF) at 1 and 6 months postpartum; neonatal Hammersmith Neonatal Neurological Examination and visual function assessment after birth; Bayley Scales of Infant and Toddler Development, Third Edition at 6 months.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Prevalence of Major Depressive Disorder Among Screened Pregnant Women
Tijdsspanne: 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.
At screening (within 20 gestational weeks)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Left Hippocampal Volume
Tijdsspanne: 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.
At Visit 1 (by 22 gestational weeks)
Right Hippocampal Volume
Tijdsspanne: 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.
At Visit 1 (by 22 gestational weeks)
Hamilton Depression Rating Scale (HDRS) Total Score at 6 Months Postpartum
Tijdsspanne: 6 months postpartum

Maternal depressive symptom severity assessed with the clinician-administered Hamilton Depression Rating Scale (HDRS). Higher scores indicate more severe depression.
6 months postpartum
Number of Depressive Relapses After Birth
Tijdsspanne: 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.
From birth to 6 months postpartum
Bayley-III Cognitive Composite Score
Tijdsspanne: 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.
6 months of age
Bayley-III Language Composite Score
Tijdsspanne: 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.
6 months of age
Bayley-III Motor Composite Score
Tijdsspanne: 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.
6 months of age

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants With Preterm Birth
Tijdsspanne: At birth

Number of participants delivering at 28 weeks or more but before 37 completed weeks of gestation.
At birth
Number of Newborns With Low Birth Weight
Tijdsspanne: At birth

Number of newborns with birth weight below 2500 grams.
At birth
Number of Newborns Small for Gestational Age
Tijdsspanne: At birth

Number of newborns classified as small for gestational age (SGA) based on birth weight for gestational age.
At birth
Number of Newborns With Apgar Score Below 7
Tijdsspanne: 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.
1 and 5 minutes after birth
Hammersmith Neonatal Neurological Examination (HNNE) Total Score
Tijdsspanne: 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.
Within the first days after birth
Edinburgh Postnatal Depression Scale (EPDS) Total Score
Tijdsspanne: 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.
1 month and 6 months postpartum

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Medewerkers

University of Milan
Instituto de Biomedicina de Sevilla
Philipps University Marburg

Onderzoekers

  • Hoofdonderzoeker: Paolo Brambilla, MD, PhD, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

29 april 2026

Primaire voltooiing (Geschat)

1 oktober 2027

Studie voltooiing (Geschat)

1 juni 2028

Studieregistratiedata

Eerst ingediend

6 november 2026

Eerst ingediend dat voldeed aan de QC-criteria

6 november 2026

Eerst geplaatst (Werkelijk)

12 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 november 2026

Laatste update ingediend die voldeed aan QC-criteria

6 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • BRAWO
  • JTC2024 - Brain-Body_BRAWO_1 (Ander subsidie-/financieringsnummer: ERA-NET NEURON (Italian Ministry of Health))
  • 6730 (Andere identificatie: Comitato Etico Territoriale Lombardia 3)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

Individual participant data sharing will be decided by the BRAWO consortium according to the Consortium Agreement and applicable data protection regulations (GDPR).

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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