Effectiveness of Repeated MOTivational InterVention to Reduce Ethanol Intake During prEgnancy
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 3
- 主要终点
- Prevalence of ethanol intake
研究概览
简要总结
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.
详细描述
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.
.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Patient (participant) will not know the arm of randomization
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Prevalence of ethanol intake
时间窗: Up to 7 days from delivery
Biomarkers: Ethyl glucuronide in mother´s hair and phosphatidylethanol in cord blood
次要结局
- 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))
研究者
Maria Dolores Gómez Roig
Head of Obstetrics and Gynecology Department
Fundació Sant Joan de Déu