Impact of Pre-Pregnancy Micronutrient Supplementation on Maternal and Child Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,011
- 试验地点
- 2
- 主要终点
- Birth Size
研究概览
简要总结
The study evaluates the efficacy of providing weekly iron-folate (IFA) supplements or Multiple Micronutrient (MM) supplements before pregnancy in increasing birth weight and duration of gestation as well as maternal and infant iron status.
详细描述
Low birth weight and anemia remain intractable problems in many developing countries despite considerable efforts to address them. Intervening with just prenatal iron-folate (IFA) supplements may not be the best approach given the substantial demands for iron by maternal and fetal tissues. Therefore, there is an urgent need to evaluate the additional contribution of prepregnancy interventions.
The study evaluates the efficacy of providing weekly iron-folate (IFA) supplements or Multiple Micronutrient (MM) supplements before pregnancy in increasing birth weight and duration of gestation as well as maternal and infant iron status.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18-35 years old
- •Currently married
- •Currently living in one of the 10 communes and intends to live in the areas for 24 months following recruitment
- •Plans to have children in the next year
- •Agrees to participate with informed consent
排除标准
- •Currently pregnant
- •Delivered in the previous six months
- •Regularly consumed IFA or MM supplements in the past 2 months
- •Severe anemia (Hb < 7 g/L)
- •History of high risk pregnancy including abruptio placenta, placenta previa, gestational diabetes, pregnancy induced hypertension, coagulation disorders, thrombocytopenia or chronic vascular, renal or systemic disease and drug use
- •Chronic hematological diseases, hereditary defects of red cells or hemoglobin
结局指标
主要结局
Birth Size
时间窗: At birth
Infants' weight, length and head circumference will be measured as early as possible within 24 hours after birth using standard procedures. All measurements will be obtained in duplicate by the same data collector. Weight-for-age and length-for-age z scores will be calculated using the 2006 WHO reference data.
Gestational Age
时间窗: At birth
Gestational age will be calculated based on the date of last menstrual period. This method has been shown to be reliable in previous work and we expect precise estimates since we will be visiting women weekly from baseline during the prepregnancy period and will exclude women who may be have delivered in the past 6 months.
Child growth
时间窗: From birth through 24 months
Length and weight will be measured at birth, 1, 3, 6, 9, 12, 15, 18, and 24 mo
Child development
时间窗: Up to 7 years post enrollment
Child development will be measured using the Bayley Scales for Infant Development III at 12 and 24 mo and the Wechsler Intelligence Scale for Children at age 6-7 y
Weight-for-age Z score (WAZ)
时间窗: Up to 7 years post enrollment
Weight-for-age Z score (WAZ) in offspring of women receiving only FA, offspring of women who receive weekly pre-pregnancy IFA, and offspring of women who receive weekly MM supplements
Body composition (Lean mass/fat free mass index)
时间窗: Up to 7 years post enrollment
Body composition (Lean mass/fat free mass index) in offspring of women receiving only FA, offspring of women who receive weekly pre-pregnancy IFA, and offspring of women who receive weekly MM supplements
Height-for-age Z score (HAZ)
时间窗: Up to 7 years post enrollment
Height-for-age Z score (HAZ) in offspring of women receiving only FA, offspring of women who receive weekly pre-pregnancy IFA, and offspring of women who receive weekly MM supplements
Weight -for-Height Z (WHZ) or Body Mass Index Z score (BMIZ)
时间窗: Up to 7 years post enrollment
Weight -for-Height Z score (WHZ) or BMIZ in offspring of women receiving only FA, offspring of women who receive weekly pre-pregnancy IFA, and offspring of women who receive weekly MM supplements
次要结局
- Maternal depression(At baseline, during pregnancy, 3 months postpartum)
- Mothers' iron status(At baseline and 1 and 3 months post partum)
- Infants' iron status(1 and 3 months of age)
研究者
Usha Ramakrishnan
Professor
Emory University