Effectiveness of Repeated MOTivational InterVention to Reduce Ethanol Intake During prEgnancy

Alcohol Abuse in Pregnancy Clinical Trial

— EMOTIVE  

Official title:

Effectiveness of Repeated MOTivational InterVention to Reduce Ethanol Intake During prEgnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04275570
• Other study ID #: PI17/0010
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: June 30, 2022

Study information

• Verified date: March 2020
• Source: Fundació Sant Joan de Déu
• Contact: María Dolores Gómez Roig, M.D, PhD
• Phone: +34932804000
• Email: lgomezroig[@]sjdhospitalbarcelona.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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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Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Abuse in Pregnancy
• Alcohol Drinking
• Alcoholism

Intervention

Behavioral:
• Motivational interview
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.

Locations

Country	Name	City	State
Spain	Centre d'Atenció a la Salut Sexual I Reproductiva of Baix Llobregat.	Barcelona
Spain	Hospital Sant Joan de Déu	Barcelona

Sponsors (5)

Lead Sponsor	Collaborator
Fundació Sant Joan de Déu	European Union, Instituto de Salud Carlos III, Red Salud Materno Infantil y del Desarrollo, University of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.; Cognitive: from 0 up to 91 (Units on a scale); Lenguage score: from 0 up to 49 on expressive communication subset score (Units on a scale), from 0 up to 48 on receptive communication subset score (Units on a scale).; Motor score: from 0 up to 66 fine motor subset score and from 0 to 72 gross motor (Units on a scale).; Minimum value: 0. Maximum values: 326. Higher scores : Better outcome.	Postnatal period: At 18 months of age.
Primary	Prevalence of ethanol intake	Biomarkers: Ethyl glucuronide in mother´s hair and phosphatidylethanol in cord blood	Up to 7 days from delivery
Secondary	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)
Secondary	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)
Secondary	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)