Status:
UNKNOWN
Effectiveness of Repeated MOTivational InterVention to Reduce Ethanol Intake During prEgnancy
Lead Sponsor:
Fundació Sant Joan de Déu
Collaborating Sponsors:
Instituto de Salud Carlos III
European Union
Conditions:
Alcohol Abuse in Pregnancy
Eligibility:
FEMALE
18-45 years
Phase:
NA
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 moti...
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 offspri...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04275570
Start Date
November 1 2018
End Date
June 30 2022
Last Update
March 19 2020
Active Locations (2)
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1
Centre d'Atenció a la Salut Sexual I Reproductiva of Baix Llobregat.
Barcelona, Spain, 43008
2
Hospital Sant Joan de Déu
Barcelona, Spain