公众健康教育对孕妇铁和叶酸补充剂服用率的影响：一项基于级联群组随机试验的研究。
Effectiveness of public health education on the uptake of iron and folic acid supplements among pregnant women: a stepped wedge cluster randomised trial.
机构信息
Department of Community Health and Epidemiology, Kenyatta University, Nairobi, Kenya
Department of Food, Nutrition and Dietetics, Kenyatta University, Nairobi, Kenya.
出版信息
BMJ Open. 2022 Sep 8;12(9):e063615. doi: 10.1136/bmjopen-2022-063615.
INTRODUCTION
Iron deficiency is the most prevalent micronutrient deficiency in pregnancy globally responsible for nearly 120 000 maternal deaths per year and a fifth of maternal mortality. Over 46% of pregnant women in Africa and 62% of pregnant women in Kenya are anaemic. Anaemia has severe economic and health consequences. Daily iron and folic acid supplementation (IFAS) is an efficacious strategy recommended in pregnancy to reduce the risk of anaemia and improve maternal and neonatal survival. However, most pregnant women do not consume IFAS as recommended. Limited knowledge on IFAS, its benefits and its connection with anaemia, and mitigation of its side effects lead to poor consumption. The main objective of this trial is to determine the effectiveness of public health education on uptake of antenatal IFAS.
METHODS AND ANALYSIS
A stepped wedge cluster randomised trial with antenatal clinics as units of randomisation. Twelve clusters will be randomised to receive the intervention and levels of IFAS uptake compared with preintervention period. The 9-month trial will enrol 1205 pregnant women. The primary outcome will be the proportion of pregnant women effectively taking up IFAS measured through self-reports, residual pill count and inspection of pill reminder cards. Routine clinical data on haemoglobin counts and fetal growth monitoring will also be used. Descriptive and bivariate analysis will be conducted in Stata using Pearson's χ test for association, and multivariate logistic regression to identify determinants of uptake. The potential public health benefits will be estimated using the number needed to treat and the preventable fraction.
ETHICS AND DISSEMINATION
Ethical approval was granted by Kenyatta University Ethics Review Committee (PKU/2443/11575). The research permit is obtained from Kenya National Commission for Science, Technology and Innovation (NACOSTI/P/22/16168). Findings will be disseminated through peer-reviewed publications and public health conferences.
TRIAL REGISTRATION NUMBER
PACTR202202775997127.
引言
缺铁是全球最普遍的微量营养素缺乏症，每年导致近 12 万孕产妇死亡，占孕产妇死亡人数的五分之一。在非洲，超过 46%的孕妇和肯尼亚 62%的孕妇患有贫血。贫血会带来严重的经济和健康后果。在怀孕期间，每日补充铁和叶酸（IFAS）是一种有效的策略，可降低贫血风险，提高母婴生存率。然而，大多数孕妇并未按照建议服用 IFAS。由于对 IFAS 的知识有限，对其益处及其与贫血的关系认识不足，以及对其副作用的缓解措施不力，导致了其服用率低。本试验的主要目的是确定公共卫生教育对接受产前 IFAS 的效果。
方法和分析
采用以产前诊所为单位进行随机分组的逐步楔形集群随机试验。将 12 个群组随机分配接受干预，并与干预前时期进行 IFAS 服用率的比较。为期 9 个月的试验将纳入 1205 名孕妇。主要结局指标是通过自我报告、剩余药丸计数和检查药丸提醒卡来衡量的有效服用 IFAS 的孕妇比例。还将使用常规临床数据评估血红蛋白计数和胎儿生长监测。在 Stata 中使用 Pearson's χ 检验进行描述性和双变量分析，以评估关联，使用多变量逻辑回归分析确定服用率的决定因素。使用需要治疗的人数和可预防的分数来估计潜在的公共卫生效益。
伦理和传播
肯尼亚塔大学伦理审查委员会（PKU/2443/11575）已批准该研究。已从肯尼亚国家科学、技术和创新委员会（NACOSTI/P/22/16168）获得研究许可证。研究结果将通过同行评议的出版物和公共卫生会议进行传播。
试验注册号
PACTR202202775997127。
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