Clinical trial with the levonorgestrel intrauterine system to measure changes in hemoglobin and serum ferritin among anemic women in Kenya

项目总结/摘要 在资源贫乏的国家，贫血症继续对边缘化妇女造成不成比例的影响。在 非洲/东南亚，超过2.7亿育龄妇女贫血。缺铁性贫血的病因 占全球孕产妇死亡的18%。需要多管齐下的方法来降低贫血的患病率 以及对家庭健康的负面影响。 每个月经周期，女性失去14至19毫克的铁，这是贫血的妇女需要铅铁 更健康的生活通过研究月经期铁丢失与膳食铁吸收之间的关系， 铁，储存铁，对血液学参数的影响是复杂的，更高水平的月经 失血与较低的血红蛋白值有关。 左炔诺孕酮宫内系统是一种高效的避孕产品， 减少经血流失。在四十多年的研究中，该产品不断提高 血红蛋白水平和增加铁储存在广大妇女，但特别是妇女与 大量经血该产品在资源贫乏的国家并不普遍， 相对于其他避孕药的成本。 作为缓解贫血的潜在工具，左炔诺孕酮宫内系统从未被 充分测试。以前的研究从未关注贫血的女性，也没有使用适当的科学方法。 确定该产品是否可以通过降低血红蛋白和铁水平来显著增加血红蛋白和铁水平的方法 月经失血 拟议研究的总体目标是让肯尼亚贫血妇女有机会尝试 左炔诺孕酮宫内系统，并与改进的科学方法，测量的影响， 血红蛋白和铁储存。在这项随机试验中，对照产品将是口服避孕药 这种药物在肯尼亚广泛使用。如果左炔诺孕酮 子宫内系统被发现工作的假设，那么该产品可以成为另一种工具，以减轻 育龄妇女贫血，从而使生活更健康，怀孕初期更健康 当需要的时候。

PROJECT SUMMARY/ABSTRACT Anemia continues to disproportionately affect marginalized women in resource-poor countries. In Africa/SE Asia, over 270 million women of reproductive age are anemic. Iron deficiency anemia causes 18% of maternal deaths worldwide. Multiprong approaches are needed to reduce the prevalence of anemia and the negative impact on family health. Every menstrual cycle, women lose 14 to 19 mg of iron; this is iron that anemic women need to lead healthier lives. Though the relationships between iron loss from menstruation, absorption of dietary intake of iron, storing iron, and the impacts on hematologic parameters are complex, higher levels of menstrual blood loss are associated with lower hemoglobin values. The levonorgestrel intrauterine system is a highly effective contraceptive product that also generally reduces menstrual blood loss. In research spanning over four decades, the product consistently raises hemoglobin levels and increases iron stores in broad populations of women, but particularly for women with heavy menstrual bleeding. This product is not widely available in resource-poor countries, due to higher costs relative to other contraceptives. As a potential tool to alleviate anemia, the levonorgestrel intrauterine system has never been adequately tested. Previous research has never focused on anemic women, nor used proper scientific approaches to determine if the product can significantly increase hemoglobin and iron levels via reducing menstrual blood loss. The overall goal of the proposed research is to give anemic women in Kenya an opportunity to try the levonorgestrel intrauterine system and with improved scientific approaches, measure the impact on hemoglobin and iron stores. In this randomized trial, the comparison product will be oral contraceptives containing iron supplement pills, which are widely available and used in Kenya. If the levonorgestrel intrauterine system is found to work as hypothesized, then the product can become another tool to alleviate anemia among reproductive-aged women, resulting in healthier living and healthier beginnings to pregnancy when desired.