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

Primary Purpose

Alcohol Abuse in Pregnancy

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Motivational interview
Sponsored by
Fundació Sant Joan de Déu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Abuse in Pregnancy focused on measuring motivational interview, pregnancy, ethanol intake

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts 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

Sites / Locations

  • Centre d'Atenció a la Salut Sexual I Reproductiva of Baix Llobregat.Recruiting
  • Hospital Sant Joan de DéuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Motivational Interview.

Usual intervention

Arm Description

Repeated motivational interview during prenatal care visits

Usual intervention

Outcomes

Primary Outcome Measures

Prevalence of ethanol intake
Biomarkers: Ethyl glucuronide in mother´s hair and phosphatidylethanol in cord blood

Secondary Outcome Measures

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).
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)
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).

Full Information

First Posted
December 17, 2019
Last Updated
March 17, 2020
Sponsor
Fundació Sant Joan de Déu
Collaborators
Instituto de Salud Carlos III, European Union, Red Salud Materno Infantil y del Desarrollo, University of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT04275570
Brief Title
Effectiveness of Repeated MOTivational InterVention to Reduce Ethanol Intake During prEgnancy
Acronym
EMOTIVE
Official Title
Effectiveness of Repeated MOTivational InterVention to Reduce Ethanol Intake During prEgnancy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundació Sant Joan de Déu
Collaborators
Instituto de Salud Carlos III, European Union, Red Salud Materno Infantil y del Desarrollo, University of Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse in Pregnancy
Keywords
motivational interview, pregnancy, ethanol intake

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster randomized simple masking controlled trial
Masking
Participant
Masking Description
Patient (participant) will not know the arm of randomization
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Motivational Interview.
Arm Type
Active Comparator
Arm Description
Repeated motivational interview during prenatal care visits
Arm Title
Usual intervention
Arm Type
No Intervention
Arm Description
Usual intervention
Intervention Type
Behavioral
Intervention Name(s)
Motivational interview
Other Intervention Name(s)
Motivational intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Prevalence of ethanol intake
Description
Biomarkers: Ethyl glucuronide in mother´s hair and phosphatidylethanol in cord blood
Time Frame
Up to 7 days from delivery
Secondary Outcome Measure Information:
Title
Prenatal neurodevelopment: Corpus Callosum (CC) assesment
Description
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).
Time Frame
Pregnancy (28 and 32 weeks of pregnancy)
Title
Prenatal neurodevelopment: Cortical development assessment
Description
Fetal neurosonography: 1. Sulcal depth measurements: Insula and Sylvian fissure, parieto-occipital, cingulate, and calcarine sulcus. Measures in millimeters (mm)
Time Frame
Pregnancy (28 and 32 weeks of pregnancy)
Title
Prenatal neurodevelopment: Cortical development assessment
Description
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).
Time Frame
Pregnancy (28 and 32 weeks of pregnancy)
Other Pre-specified Outcome Measures:
Title
Postnatal development
Description
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.
Time Frame
Postnatal period: At 18 months of age.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participants must be pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
María Dolores Gómez Roig, M.D, PhD
Phone
+34932804000
Ext
71390
Email
lgomezroig@sjdhospitalbarcelona.org
First Name & Middle Initial & Last Name or Official Title & Degree
Paz Ahumada, M.D
Phone
+34932804000
Ext
71363
Email
pahumada@sjdhospitalbarcelona.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paz Ahumada, M.D
Organizational Affiliation
Hospital Sant Joan de Deu
Official's Role
Study Chair
Facility Information:
Facility Name
Centre d'Atenció a la Salut Sexual I Reproductiva of Baix Llobregat.
City
Barcelona
ZIP/Postal Code
43008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paz Ahumada, M.D
Phone
+34932804000
Ext
71363
Email
pahumada@sjdhospitalbarcelona.org
Facility Name
Hospital Sant Joan de Déu
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paz Ahumada, M.D
Phone
+34932804000
Ext
71363
Email
pahumada@sjdhospitalbarcelona.org
First Name & Middle Initial & Last Name & Degree
María Dolores Gómez Roig, M.D, PhD
Phone
+34932804000
Ext
71390
Email
lgomezroig@sjdhospitalbarcelona.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of Repeated MOTivational InterVention to Reduce Ethanol Intake During prEgnancy

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