Targeting Strategies of Antenatal Balanced Energy and Protein Supplementation in Addis Ababa, Ethiopia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7,851
- 试验地点
- 2
- 主要终点
- Small-for-gestational-age births
研究概览
简要总结
The goal of this randomized effectiveness study is to evaluate the different targeting strategies for the delivery of balanced energy and protein (BEP) supplements among pregnant women in Addis Ababa, Ethiopia. The main goals of the study are to: 1) determine the effectiveness of two individual-based antenatal BEP targeting strategies for preventing adverse pregnancy outcomes; 2) compare the cost-effectiveness of the universal BEP provision with two individual-based targeting strategies for preventing adverse pregnancy outcomes; and 3) generate implementation evidence regarding the feasibility and acceptability of different antenatal BEP targeting strategies. Pregnant women will be enrolled during pregnancy, assigned to different strategies of BEP supplementation, and followed from pregnancy through six weeks postpartum to evaluate the impacts of different BEP targeting strategies on pregnancy, maternal, and child outcomes.
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
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant women aged 18 to 49;
- •attending antenatal visits in one of the study health facilities;
- •with a gestational age of 24 weeks or less;
- •no known allergies to peanuts or soybeans;
- •having resided in the current location for at least 6 months;
- •intending to continue antenatal follow-up in the health facility;
- •intending to give birth and remain in the study area until six weeks after delivery; and
- •willing to take the BEP supplements for the entire duration of the pregnancy if eligible.
排除标准
- •Not meeting all of the inclusion criteria above
研究组 & 干预措施
Arm 4 (universal BEP)
干预措施: Universal BEP (Dietary Supplement)
Arm 3 (Targeted BEP by baseline nutritional status and monthly gestational weight gain monitoring)
干预措施: Targeted BEP based on baseline nutritional status and monthly GWG monitoring (Dietary Supplement)
Arm 1 (control arm)
In Arm 1 (control arm), participants will receive the standard of antenatal care including iron and folic acid supplementation.
Arm 2 (Targeted BEP based on baseline nutritional status)
干预措施: Targeted BEP based on baseline nutritional status (Dietary Supplement)
结局指标
主要结局
Small-for-gestational-age births
时间窗: Assessed within 72 hours of birth
Live birth whose birthweight for sex and gestational age is \< 10th percentile based on the INTERGROWTH-21st standards
次要结局
- Macrosomia(Assessed within 72 hours of birth)
- Pre-eclampsia(After 20 weeks of gestation)
- Stillbirth(Between 28 weeks of gestation and delivery)
- Preterm birth(Less than 37 completed weeks of gestation)
- Neonatal death(From birth through 28 days of life)
- Perinatal death(Between 28 weeks of gestation to 7 days after delivery)
- Inadequate gestational weight gain(At the last weight measurement before delivery, at around 36 weeks)
- Excessive gestational weight gain(At the last weight measurement before delivery, at around 36 weeks)
- Large-for-gestational-age births(Assessed within 72 hours of birth)
- Low birthweight(Assessed within 72 hours of birth)
- Third-trimester anemia(At 32 weeks of gestation)
研究者
Wafaie Fawzi
Richard Saltonstall Professor of Population Sciences, and Professor of Nutrition, Epidemiology, and Global Health
Harvard School of Public Health (HSPH)