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

March 17, 2020 updated by: Maria Dolores Gómez Roig, Fundació Sant Joan de Déu
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Motivational Interview.
Repeated motivational interview during prenatal care visits
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.
Other Names:
  • Motivational intervention
No Intervention: Usual intervention

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prenatal neurodevelopment: Corpus Callosum (CC) assesment
Time Frame: 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).
Pregnancy (28 and 32 weeks of pregnancy)
Prenatal neurodevelopment: Cortical development assessment
Time Frame: Pregnancy (28 and 32 weeks of pregnancy)

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)
Prenatal neurodevelopment: Cortical development assessment
Time Frame: 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).
Pregnancy (28 and 32 weeks of pregnancy)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postnatal development
Time Frame: Postnatal period: At 18 months of age.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Sant Joan de Déu

Collaborators

Instituto de Salud Carlos III
European Union
University of Barcelona
Red Salud Materno Infantil y del Desarrollo

Investigators

  • Study Chair: Paz Ahumada, M.D, Hospital Sant Joan de Déu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

December 17, 2019

First Submitted That Met QC Criteria

February 17, 2020

First Posted (Actual)

February 19, 2020

Study Record Updates

Last Update Posted (Actual)

March 19, 2020

Last Update Submitted That Met QC Criteria

March 17, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI17/0010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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