Alcohol Abuse in Pregnancy Clinical Trial
— EMOTIVEOfficial title:
Effectiveness of Repeated MOTivational InterVention to Reduce Ethanol Intake During prEgnancy
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.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | June 30, 2022 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Centre d'Atenció a la Salut Sexual I Reproductiva of Baix Llobregat. | Barcelona | |
Spain | Hospital Sant Joan de Déu | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Fundació Sant Joan de Déu | European Union, Instituto de Salud Carlos III, Red Salud Materno Infantil y del Desarrollo, University of Barcelona |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. |
Postnatal period: At 18 months of age. | |
Primary | Prevalence of ethanol intake | Biomarkers: Ethyl glucuronide in mother´s hair and phosphatidylethanol in cord blood | Up to 7 days from delivery | |
Secondary | 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). |
Pregnancy (28 and 32 weeks of pregnancy) | |
Secondary | 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) |
Pregnancy (28 and 32 weeks of pregnancy) | |
Secondary | 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). |
Pregnancy (28 and 32 weeks of pregnancy) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01961050 -
Preventing FAS/ARND in Russian Children
|
N/A |