Alcohol Abuse in PregnancyEMOTIVENCT04275570
Effectiveness of Repeated MOTivational InterVention to Reduce Ethanol Intake During prEgnancy
A study testing Motivational interview in people with Alcohol Abuse in Pregnancy, run by Fundació Sant Joan de Déu at 2 sites in Spain.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohol Abuse in Pregnancy
- What is being tested?
- Motivational interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Nov 2018to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Imposibility to obtain the sample (hair lenght below nine centimeters)
- Discolored hair
- Refusal to join the study
Trial locations and contacts
2 sites in 1 country.
María Dolores Gómez Roig, M.D, PhD contact
Spain2 sites, 2 recruiting
- Recruiting
Centre d'Atenció a la Salut Sexual I Reproductiva of Baix Llobregat.
Barcelona, 43008
Paz Ahumada, M.D, +34932804000 ext. 71363, pahumada@sjdhospitalbarcelona.org
- Recruiting
Hospital Sant Joan de Déu
Barcelona
Paz Ahumada, M.D, +34932804000 ext. 71363, pahumada@sjdhospitalbarcelona.org
María Dolores Gómez Roig, M.D, PhD, +34932804000 ext. 71390, lgomezroig@sjdhospitalbarcelona.org
About this study
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.
.
- Conditions
- Alcohol Abuse in Pregnancy
- Being tested
- Motivational interview
- Keywords
- motivational interview, pregnancy, ethanol intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewBehavioural
Also called Motivational intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interview. | Active comparator | Repeated motivational interview during prenatal care visits Receives: Behavioral: Motivational interview |
| Usual intervention | No intervention | Usual intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of ethanol intake
Biomarkers: Ethyl glucuronide in mother´s hair and phosphatidylethanol in cord blood
Measured: Up to 7 days from delivery
Secondary outcomes (3)
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).
Measured: Pregnancy (28 and 32 weeks of pregnancy)
Prenatal neurodevelopment: Cortical development assessment
Fetal neurosonography:
- Sulcal depth measurements: Insula and Sylvian fissure, parieto-occipital, cingulate, and calcarine sulcus. Measures in millimeters (mm)
Measured: Pregnancy (28 and 32 weeks of pregnancy)
Prenatal neurodevelopment: Cortical development assessment
Fetal neurosonography:
- 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).
Measured: Pregnancy (28 and 32 weeks of pregnancy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start1 Nov 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Abuse in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized simple masking controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, European Union, Red Salud Materno Infantil y del Desarrollo, University of Barcelona
- Responsible party
- Principal investigator, Maria Dolores Gómez Roig, Fundació Sant Joan de Déu
- Investigators
- Paz Ahumada, M.D, Study chair, Hospital Sant Joan de Deu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275570
- Sponsor's protocol ID
- PI17/0010
- Acronym
- EMOTIVE
- Status last verified
- Mar 2020
- First submitted
- 17 Dec 2019
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Repeated MOTivational InterVention to Reduce Ethanol Intake During prEgnancy
- ClinicalTrials.gov ID
- NCT04275570
- Acronym / sponsor ID
- EMOTIVE / PI17/0010
- Conditions
- Alcohol Abuse in Pregnancy
- Keywords
- motivational interview, pregnancy, ethanol intake
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, European Union, Red Salud Materno Infantil y del Desarrollo, University of Barcelona
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Cluster randomized simple masking controlled trial
| Arm | Type | Receives |
|---|---|---|
| Motivational Interview. | Active comparator | Behavioral: Motivational interviewRepeated motivational interview during prenatal care visits |
| Usual intervention | No intervention | –Usual intervention |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational interviewAlso: Motivational interventionThe 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. | Behavioural | Motivational Interview. |
Primary outcome
Prevalence of ethanol intake
Time frame: Up to 7 days from delivery
Biomarkers: Ethyl glucuronide in mother´s hair and phosphatidylethanol in cord blood
3 secondary outcomes
Prenatal neurodevelopment: Corpus Callosum (CC) assesment
Time frame: Pregnancy (28 and 32 weeks of pregnancy)
Prenatal neurodevelopment: Cortical development assessment
Time frame: Pregnancy (28 and 32 weeks of pregnancy)
Prenatal neurodevelopment: Cortical development assessment
Time frame: Pregnancy (28 and 32 weeks of pregnancy)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Alcohol Abuse in Pregnancy
Enrolling by invitationObservational study
Alcohol and Cannabis Use Among Pregnant Slovenian Women
Microbiome Analysis, Drug Abuse in Pregnancy
Recruiting
The Oklahoma Parent-Child Assistance Program
Substance Use Disorders, Pregnancy Related
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María Dolores Gómez Roig, M.D, PhD contact
Paz Ahumada, M.D study chair
Hospital Sant Joan de Deu
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interview in people with Alcohol Abuse in Pregnancy, run by Fundació Sant Joan de Déu at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact María Dolores Gómez Roig, M.D, PhD (+34932804000 ext. 71390, lgomezroig@sjdhospitalbarcelona.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of ethanol intake (time frame: Up to 7 days from delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020.