Alcohol Abuse in Pregnancy
Conditions
Keywords
motivational interview, pregnancy, ethanol intake
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. .
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.
Sponsors
Instituto de Salud Carlos III
European Union
Red Salud Materno Infantil y del Desarrollo
University of Barcelona
Fundació Sant Joan de Déu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Patient (participant) will not know the arm of randomization
Intervention model description
Cluster randomized simple masking controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of ethanol intake | Up to 7 days from delivery | Biomarkers: Ethyl glucuronide in mother´s hair and phosphatidylethanol in cord blood |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prenatal neurodevelopment: Corpus Callosum (CC) assesment | 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). |
| Prenatal neurodevelopment: Cortical development assessment | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Postnatal development | 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. |
Countries
Spain
Contacts
Primary ContactMaría Dolores Gómez Roig, M.D, PhD
Backup ContactPaz Ahumada, M.D
Outcome results
None listed