The 1000 First Day of Life : Effect of Multi Micronutrients Supplementation on Pregnancy Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- Maternal Outcome
研究概览
简要总结
To monitor the effects of multi micronutrients supplementations during pregnancy towards pregnancy outcomes
详细描述
A randomized control trial of two clusters :
1st cluster without giving multi micronutrients; 2nd cluster giving multi micronutrients.
Differences between cluster : Additional multi micronutrients by giving : Complete multi micronutrients, calcium, vitamin D and DHA. The additional multi micronutrients were given since 1st until 3rd trimester for interventions group. There are also additional laboratory examinations for intervention group : Vitamin D, Lipid Profile and Zinc level.
In control group : we use standard public health care micronutrients (Iron supplementation and calcium); and standard blood examinations.
Ultrasound examination was performed for both cluster since 1st until 3rd trimester.
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
- None
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •First trimester pregnancy
- •Gestational age < 10 weeks gestation
- •Agree as research participant
- •Living in DKI Jakarta
排除标准
- •Assisted Reproductive
- •History of PCOS
- •History of Chronic Hypertension
- •History of Diabetes Mellitus
- •History of Preeclampsia
- •Maternal chronic disease : Cardiovascular disease; Autoimmune condition; Malignancy)
- •Plan to move from Jakarta prior or during pregnancy
- •History of Recurrent pregnancy loss
结局指标
主要结局
Maternal Outcome
时间窗: 1 year
Maternal Death; Preterm Delivery; Preeclampsia; Intrauterine Infections; Post partum hemorrhage
Perinatal Outcome
时间窗: 1 year
Neonatal death; Low birth weight; Intra uterine growth restriction; Asphyxia
次要结局
未报告次要终点
研究者
Rima Irwinda
MD, OBGYN, PhD
Dr Cipto Mangunkusumo General Hospital