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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
| European Union | OTHER |
| Red Salud Materno Infantil y del Desarrollo | OTHER |
| University of Barcelona |
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Ethanol exposure during pregnancy is associated with adverse perinatal outcomes resulting in high healthcare costs. Primary care centers whose attends low risk women will be randomized to apply a motivational intervention program to the mothers.
This is a cluster randomized simple masking controlled trial evaluating the effectiveness of repeated motivational interview (MI) during pregnancy on prevalence of ethanol intake together with offspring´s neurodevelopment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motivational Interview. | Active Comparator | Repeated motivational interview during prenatal care visits |
|
| Usual intervention | No Intervention | Usual intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational interview | Behavioral | The motivational interview is integrated in a structural theoretical mark. This method is a person-centered counseling style that increases the intrinsic motivation of the patient to behavioral changes through spirit, acceptance, compassion and evocation. |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of ethanol intake | Biomarkers: Ethyl glucuronide in mother´s hair and phosphatidylethanol in cord blood | Up to 7 days from delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Prenatal neurodevelopment: Corpus Callosum (CC) assesment | Fetal neurosonography:
| Pregnancy (28 and 32 weeks of pregnancy) |
| Measure | Description | Time Frame |
|---|---|---|
| Postnatal development | Bayley III test: This test evaluate mental and motor development and also children behavior. It will be performed at 18 months of age. Measures in units on a scale.
Minimum value: 0. Maximum values: 326. Higher scores : Better outcome. |
Inclusion Criteria:
Exclusion Criteria:
Participants must be pregnant women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| María Dolores Gómez Roig, M.D, PhD | Contact | +34932804000 | 71390 | lgomezroig@sjdhospitalbarcelona.org |
| Paz Ahumada, M.D | Contact | +34932804000 | 71363 | pahumada@sjdhospitalbarcelona.org |
| Name | Affiliation | Role |
|---|---|---|
| Paz Ahumada, M.D | Hospital Sant Joan de Deu | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre d'Atenció a la Salut Sexual I Reproductiva of Baix Llobregat. | Recruiting | Barcelona | 43008 | Spain |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 29, 2018 | Jan 2, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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| OTHER |
Cluster randomized simple masking controlled trial
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Patient (participant) will not know the arm of randomization
|
|
| Prenatal neurodevelopment: Cortical development assessment |
Fetal neurosonography: 1. Sulcal depth measurements: Insula and Sylvian fissure, parieto-occipital, cingulate, and calcarine sulcus. Measures in millimeters (mm) |
| Pregnancy (28 and 32 weeks of pregnancy) |
| Prenatal neurodevelopment: Cortical development assessment | Fetal neurosonography: 2. Cortical maturation grading (temporal area, Sylvian fissure, superior temporal sulcus ,frontal and parietal area and parieto-occipital sulcus, mesial area and cingulate sulcus and calcarine sulcus). | Pregnancy (28 and 32 weeks of pregnancy) |
| Postnatal period: At 18 months of age. |
| Hospital Sant Joan de Déu | Recruiting | Barcelona | Spain |
|
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |