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Status unknownNCT04275570EMOTIVEUpdated Mar 19, 2020

Effectiveness of Repeated MOTivational InterVention to Reduce Ethanol Intake During prEgnancy

An interventional study of Motivational interview in Alcohol Abuse in Pregnancy, sponsored by Fundació Sant Joan de Déu. Status unknown at 2 sites in Spain. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-19.

Sponsored by Fundació Sant Joan de Déu · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Nov 2018, registered Dec 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Alcohol Abuse in Pregnancy

Keywords

  • motivational interview
  • pregnancy
  • ethanol intake
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In context

Lead sponsor

Fundació Sant Joan de Déu is the lead sponsor of 70 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
600 participants (estimated)

Study arms

  • Active comparator
    Motivational Interview.

    Repeated motivational interview during prenatal care visits

    Behavioral: Motivational interview

  • No intervention
    Usual intervention

    Usual intervention

Interventions

  • BehavioralMotivational 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.

    Also known as: Motivational intervention

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What researchers measure

Primary outcomes

  1. Prevalence of ethanol intake

    Biomarkers: Ethyl glucuronide in mother´s hair and phosphatidylethanol in cord blood

    Time frame: Up to 7 days from delivery

Secondary outcomes

  1. Prenatal neurodevelopment: Corpus Callosum (CC) assesment

    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).

    Time frame: Pregnancy (28 and 32 weeks of pregnancy)

  2. 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)

    Time frame: Pregnancy (28 and 32 weeks of pregnancy)

  3. 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).

    Time frame: Pregnancy (28 and 32 weeks of pregnancy)

Other outcomes

  1. 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.

    Time frame: Postnatal period: At 18 months of age.

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Study locations

2 of 2 sites recruiting
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References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2018 (actual). Primary completion is estimated for Dec 2020, 25 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 17, 2019
First posted
Feb 19, 2020
StartActual
Nov 1, 2018
Primary completionEst.
Dec 31, 2020
CompletionEst.
Jun 30, 2022
Last update
Mar 19, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04275570
Lead sponsor
Fundació Sant Joan de Déu
Collaborators
Instituto de Salud Carlos III, European Union, Red Salud Materno Infantil y del Desarrollo, University of Barcelona
Responsible party
Maria Dolores Gómez Roig (Head of Obstetrics and Gynecology Department, Fundació Sant Joan de Déu) — Principal investigator
First posted
Feb 19, 2020
Start date
Nov 1, 2018
Primary completion
Dec 31, 2020 (estimated)
Completion
Jun 30, 2022 (estimated)
Last update
Mar 19, 2020

Study contacts

María Dolores Gómez Roig, M.D, PhD
Contact
lgomezroig@sjdhospitalbarcelona.org
+34932804000 ext. 71390
Paz Ahumada, M.D
Contact
pahumada@sjdhospitalbarcelona.org
+34932804000 ext. 71363
Paz Ahumada, M.D
study chair · Hospital Sant Joan de Deu

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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