Effectiveness of Repeated MOTivational InterVention to Reduce Ethanol Intake During prEgnancy

Not Applicable

• Conditions: Alcohol Abuse in Pregnancy

• Registration Number: NCT04275570
• Lead Sponsor: Fundació Sant Joan de Déu

Brief Summary

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

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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Study Timeline

• Study Start: 2018-11-01
• Study First Submitted: 2019-12-17
• Study First Submitted QC: 2020-02-17
• Study First Posted: 2020-02-19
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-19
• Primary Completion: 2020-12-31
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Prevalence of ethanol intake	Up to 7 days from delivery	Biomarkers: Ethyl glucuronide in mother´s hair and phosphatidylethanol in cord blood

Secondary Outcome Measures

Name	Time	Method
Prenatal neurodevelopment: Corpus Callosum (CC) assesment	Pregnancy (28 and 32 weeks of pregnancy)	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).
Prenatal neurodevelopment: Cortical development assessment	Pregnancy (28 and 32 weeks of pregnancy)	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).

Trial Locations

Locations (2)

Centre d'Atenció a la Salut Sexual I Reproductiva of Baix Llobregat.; 🇪🇸 Barcelona, Spain

Hospital Sant Joan de Déu; 🇪🇸 Barcelona, Spain