Effectiveness of Repeated MOTivational InterVention to Reduce Ethanol Intake During prEgnancy

Study Overview
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Brief Summary
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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.

Detailed Description
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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. .

Official Title
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Effectiveness of Repeated MOTivational InterVention to Reduce Ethanol Intake During prEgnancy

Conditions
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Alcohol Abuse in Pregnancy

Intervention / Treatment
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* Behavioral: Motivational interview


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Maternal age at recruitment > 18 years Speak Spanish fluenty Women controlling their pregnancy in Baix Llobregat Center and Hospital Sant Joan de Déu, who will attend their delivery in Hospital Sant Joan de Déu and Parc Sanitari Sant Joan de Déu Viable singleton non- malformed fetus First trimestre of gestation Exclusion Criteria: Multiple gestations Perinatal infections Fetal anomalies including chromosomal anormalities or structural malformations detected by ultrasound Premature rupture of membranes Uncontrolled or/and severe maternal chronic disease Language barriers Imposibility to obtain the sample (hair lenght below nine centimeters) Discolored hair Refusal to join the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster randomized simple masking controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Motivational Interview.<br>Repeated motivational interview during prenatal care visits | Behavioral: Motivational interview<br>* 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.<br>* Other names: Motivational intervention;|
| No Intervention: Usual intervention<br>Usual intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prenatal neurodevelopment: Corpus Callosum (CC) assesment | Fetal neurosonography: CC total area, measures in square centimeters (cm2) CC's areas after a subdivision in 7 portions: rostrum, genu, rostral body, anterior midbody, posterior midbody, isthmus and splenium (cm2). | Pregnancy (28 and 32 weeks of pregnancy) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnancy, motivational interview, ethanol intake