NCT04275570

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 19, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

March 19, 2020

Status Verified

March 1, 2020

Enrollment Period

2.2 years

First QC Date

December 17, 2019

Last Update Submit

March 17, 2020

Conditions

Alcohol Abuse in Pregnancy

Keywords

motivational interviewpregnancyethanol intake

Outcome Measures

Primary Outcomes (1)

  • Prevalence of ethanol intake

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

    Up to 7 days from delivery

Secondary Outcomes (3)

  • Prenatal neurodevelopment: Corpus Callosum (CC) assesment

    Pregnancy (28 and 32 weeks of pregnancy)

  • Prenatal neurodevelopment: Cortical development assessment

    Pregnancy (28 and 32 weeks of pregnancy)

  • Prenatal neurodevelopment: Cortical development assessment

    Pregnancy (28 and 32 weeks of pregnancy)

Other Outcomes (1)

  • Postnatal development

    Postnatal period: At 18 months of age.

Study Arms (2)

Motivational Interview.

ACTIVE COMPARATOR

Repeated motivational interview during prenatal care visits

Behavioral: Motivational interview

Usual intervention

NO INTERVENTION

Usual intervention

Interventions

Motivational interviewBEHAVIORAL

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
Motivational Interview.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipants must be pregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre d'Atenció a la Salut Sexual I Reproductiva of Baix Llobregat.

Barcelona, 43008, Spain

RECRUITING

Hospital Sant Joan de Déu

Barcelona, Spain

RECRUITING

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Paz Ahumada, M.D

    Hospital Sant Joan de Deu

    STUDY CHAIR

Central Study Contacts

María Dolores Gómez Roig, M.D, PhD

CONTACT

+34932804000lgomezroig@sjdhospitalbarcelona.org

Paz Ahumada, M.D

CONTACT

+34932804000pahumada@sjdhospitalbarcelona.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patient (participant) will not know the arm of randomization
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Cluster randomized simple masking controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Obstetrics and Gynecology Department

Study Record Dates

First Submitted

December 17, 2019

First Posted

February 19, 2020

Study Start

November 1, 2018

Primary Completion

December 31, 2020

Study Completion

June 30, 2022

Last Updated

March 19, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)