Effectiveness of Repeated MOTivational InterVention to Reduce Ethanol Intake During prEgnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2022-06-30

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.

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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.

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Conditions

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Alcohol Abuse in Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster randomized simple masking controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Patient (participant) will not know the arm of randomization

Study Groups

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Motivational Interview.

Repeated motivational interview during prenatal care visits

Group Type ACTIVE_COMPARATOR

Motivational interview

Intervention Type BEHAVIORAL

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.

Usual intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Motivational intervention

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes