Trial of Pre-Pregnancy Supplements
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 802
- 试验地点
- 1
- 主要终点
- Anemia
研究概览
简要总结
The purpose of this study is to determine whether daily oral supplements of multivitamins (including vitamins B-complex, C and E) along with Iron and folic acid given to non-pregnant women results in lower prevalence of anemia in preparation for pregnancy when compared to daily iron and folic acid supplements or folic acid alone.
详细描述
Globally, more than half a million women die from pregnancy or childbirth-related complications, most of them in developing countries. The global community committed to reducing the maternal mortality ratio by three quarters between 1990 and 2015 (MDG5). Women die from a range of complications in pregnancy, childbirth or the postpartum period. 80% of maternal deaths are due to severe bleeding (mostly bleeding postpartum), infections, hypertensive disorders in pregnancy and obstructed labor. Additionally, low birth weight and neonatal mortality are common problems in developing countries. The benefit of periconceptual folate on preventing congenital anomalies has been established in randomized trials; however, the role of other nutrients needs to be examined further. Anemia is strongly associated with adverse perinatal outcomes including maternal mortality and low birthweight.
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
- 15 Years 至 29 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Girls aged > =15 years and <= 29 years
- •Have not missed a menstrual period during recruitment (no amenorrhea)
- •Has not been pregnant or given birth within the last 6 months
- •Intend to stay in the study area for at least 6 months after enrollment
- •Have provided written informed consent
排除标准
- •Amenorrhea or confirmed pregnancy at screening or enrollment.
- •Has given birth within 6 months
- •Already taking long-term vitamin supplementation.
- •Any severe illness requiring hospitalization at screening or enrollment (women who have been deemed to have recovered will be eligible once they return home).
结局指标
主要结局
Anemia
时间窗: 6 months following the start of the intervention
Anemia will be defined as hemoglobin \< 12gm/dL at 6 months of intervention. Hemoglobin concentration will also be analyzed as a continuous outcome.
次要结局
- Weight Gain during intervention(6 months following the start of the intervention)
- Mid Upper Arm Circumference(6 months following the start of the intervention)
- Peripheral malaria parasitemia(6 months following the start of the intervention)
研究者
Wafaie Fawzi
Chair, Department of Global Health and Population
Harvard School of Public Health (HSPH)