Improving Mothers for a Better PrenAtal Care Trial Barcelona
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,221
- 试验地点
- 3
- 主要终点
- Fetal Growth Restriction (FGR)
研究概览
简要总结
High risk women for growth restricted fetuses will randomized in the second trimester into different strategies applied to the mothers: a stress reduction program based on mindfulness techniques or a nutrition interventional program based on Mediterranean diet.
详细描述
Randomized controlled trial among women at higher risk to have a growth restricted fetus (30%) according to Royal College of Obstetrics and Gynecology (RCOG) Guidelines. These high-risk women will be randomized in order to evaluate an improvement in several outcomes thanks to different strategies applied to the mothers: a stress reduction program based on mindfulness techniques or a nutrition interventional program based on Mediterranean diet.
Main hypothesis: specific interventions improving maternal lifestyle and well being have a positive impact on pregnancy outcomes as well as on fetal growth and development.
Secondary hypothesis is that interventions to improve maternal lifestyle well being have a positive impact on offspring's outcome later in life, in terms of neurodevelopment and cardiovascular profile, mediated by epigenetic changes in offspring.
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 (Care Provider)
盲法说明
Care provider will not know the arm of randomization
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Maternal age at recruitment ≥18 years
- •Speak Spanish fluently
- •Viable singleton non-malformed fetus
- •High-risk pregnancy to develop FGR.
- •19-23 weeks of gestation
排除标准
- •Fetal anomalies including chromosomal abnormalities or structural malformations detected by ultrasound.
- •Mental retardation or other mental or psychiatric disorders that impose doubts regarding the true patient´s willingness to participate in the study.
- •No possibility to come to additional visits.
结局指标
主要结局
Fetal Growth Restriction (FGR)
时间窗: Delivery
Birth weight \<10th percentile
次要结局
- Adverse Perinatal Outcome (APO) Adverse Perinatal Outcome (APO)(Pregnancy)
研究者
Eduard Gratacós Solsona
Director of ICGON and BCNatal
Hospital Clinic of Barcelona