Effectiveness of Repeated MOTivational InterVention to Reduce Ethanol Intake During prEgnancy

Fundació Sant Joan de Déu600 enrolled

Overview

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. .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

600

Conditions

Alcohol Abuse in Pregnancy

Interventions

Motivational interviewBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Centre d'Atenció a la Salut Sexual I Reproductiva of Baix Llobregat.

Barcelona, Spain

RECRUITING

Hospital Sant Joan de Déu

Barcelona, Spain

RECRUITING

Outcomes

Primary Outcomes

Prevalence of ethanol intake

Biomarkers: Ethyl glucuronide in mother´s hair and phosphatidylethanol in cord blood

Time frame: Up to 7 days from delivery

Secondary Outcomes

Prenatal neurodevelopment: Corpus Callosum (CC) assesment

Fetal neurosonography: 1. CC total area, measures in square centimeters (cm2) 2. CC's areas after a subdivision in 7 portions: rostrum, genu, rostral body, anterior midbody, posterior midbody, isthmus and splenium (cm2).

Time frame: 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)

Time frame: 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).

Time frame: Pregnancy (28 and 32 weeks of pregnancy)

Central Contacts

María Dolores Gómez Roig, M.D, PhD

CONTACT

+34932804000 lgomezroig@sjdhospitalbarcelona.org

Paz Ahumada, M.D

CONTACT

+34932804000 pahumada@sjdhospitalbarcelona.org

Data from ClinicalTrials.gov

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