Women First: Preconception Maternal Nutrition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7,374
- 试验地点
- 5
- 主要终点
- Neonatal linear growth
研究概览
简要总结
Multi-country three-arm, individually randomized, non-masked, controlled trial to ascertain the benefits of ensuring optimal maternal nutrition before conception and providing an evidence base for programmatic priority directed to minimizing the risk of malnutrition in all females of reproductive age.
详细描述
The objective is to determine the benefits to the offspring of women in poor, food-insecure environments of commencing a daily comprehensive maternal nutrition supplement (with additional balanced calorie/protein supplement for underweight participants) ≥ 3 months prior to conception versus the benefits of commencing the same supplement at 12 weeks gestation and also to compare offspring outcomes with those of a control group which receives no supplement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •16-35 years of age;
- •expectation to have first or further pregnancy without intent to utilize contraception
- •Hb >8 g/dL
排除标准
- •Nulliparous women who do not agree to hospital delivery (equipped for caesarian section) or/and do not have ready access to such a facility.
结局指标
主要结局
Neonatal linear growth
时间窗: <24 hours of age
Research assistants will obtain neonatal length measurement at \<24 hours of age.
次要结局
- Estimate fetal growth(12 weeks gestation)
- Epigenome (Infant)(2 weeks and 3 months of age)
- Microbiome (infant)(14 days and 3 months of age (infant))
- Length-for-age Z-scores(age 0.5, 1, 3, 6, 12, 18 and 24 months postnatal)
- Incidence of low birth weight (LBW) infants(at birth)
- Perinatal Mortality(From 20 weeks gestation through 1 month of age)
- Incidence of severe neonatal and infant infectious disease(birth to 6 months of age)
- Neurodevelopment assessment(24 mo age)
- Epigenome (Maternal)(baseline, 12 and 34 weeks gestation, delivery, and 3 months postpartum (maternal); 2 weeks and 3 months of age (infant))
- Microbiome (maternal)(12 & 34 weeks gestation and delivery (maternal))
- Composition of breast milk(14 days postpartum)
- Gestational weight gain (GWG)(Enrollment to delivery)
- Mean birth weight(at birth)
- Deep phenotyping of maternal metabolic and nutritional status(12 and 34 weeks gestation, delivery, and 3 months postpartum)