Effectiveness of Repeated MOTivational InterVention to Reduce Ethanol Intake During prEgnancy (EMOTIVE)

Fundació Sant Joan de Déu

Status

Unknown

Conditions

Alcohol Abuse in Pregnancy

Treatments

Behavioral: Motivational interview

Study type

Interventional

Funder types

Other

Identifiers

NCT04275570

PI17/0010

Details and patient eligibility

About

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.

Full 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.

Enrollment

600 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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