电话干预以应对孕期口服铁叶酸补充剂依从性不佳的情况：一项随机对照试验。
Telephonic intervention to combat non-adherence to oral iron-folic acid supplementation in pregnancy: A randomized controlled trial.
作者信息
Sharma Sakshi, Smitha M V, Balakrishnan Deepthy
机构信息
College of Nursing, All India Institute of Medical Sciences, Bhubaneswar, Odisha 751019, India.
All India Institute of Medical Sciences, Gorakhpur, Uttar Pradesh 273008, India.
出版信息
Eur J Obstet Gynecol Reprod Biol X. 2023 Sep 9;20:100235. doi: 10.1016/j.eurox.2023.100235. eCollection 2023 Dec.
INTRODUCTION
Iron deficiency anemia is a public health problem globally attributing to high incidences of maternal and infant mortality and morbidity. Iron and folic acid supplementation (IFAS) is essential and provided free of cost by the public health sectors, however, a systematic review shows that the national-level adherence to oral Iron-Folic Acid Supplementation (IFAS) is less than half in pregnant women, and the significant obstacles to non-adherence are fear of side effects and forgetfulness. This trial was designed to mitigate the side effects and tackle forgetfulness with telephonic intervention. The objectives were to investigate the effectiveness of the telephonic intervention on oral IFAS adherence and hemoglobin and the reasons for non-adherence to oral IFAS, to find out the proportion of anemia in the study population, and to assess the effectiveness of the intervention on maternal and neonatal outcomes.
METHODS
Hospital-based open-label multi-centric parallel-group randomized controlled trial, used block randomization and allocated treatment in a 1:1 ratio recruited 286 anemic pregnant women between 14 and 24 weeks of gestation with hemoglobin level < 11 g/dl having smartphones at a secondary hospital and a tertiary hospital in Eastern India. The experimental group received telephonic intervention for one month via structured text reminders, WhatsApp audio messages, and phone calls. The standard course of treatment was given to the control group.
RESULTS
286 women (n =143, n =143) were randomized, 36 had attrition leaving 250 for analysis (n =123, n =127), the experimental group experienced a 44.9 % and the control group 13.8 % increase in adherence ( < 0.001). The leading reasons for non-adherence were forgetfulness (24 %), nausea and vomiting (23.2 %), and constipation (18.8 %). Hemoglobin level increased by 0.8 g/dl ( < 0.001) in the experimental group and 0.2 g/dl ( < 0.807) in the control group.
CONCLUSION
In addition to improving adherence to oral IFAS, telephonic intervention mitigates side effects and enhances hemoglobin in anemic pregnant women. The increase in adherence was threefold in the experimental group compared to a marginal rise in the control group. This study recommends the implementation of a telephonic intervention to promote adherence to oral IFAS among anemic pregnant women.
引言
缺铁性贫血是一个全球性的公共卫生问题，与母婴高死亡率和发病率相关。铁和叶酸补充剂（IFAS）至关重要，由公共卫生部门免费提供，然而，一项系统评价显示，在孕妇中，全国范围内口服铁叶酸补充剂（IFAS）的依从性不到一半，不依从的主要障碍是担心副作用和遗忘。本试验旨在通过电话干预减轻副作用并解决遗忘问题。目标是调查电话干预对口服IFAS依从性和血红蛋白的有效性以及不口服IFAS的原因，找出研究人群中的贫血比例，并评估干预对孕产妇和新生儿结局的有效性。
方法
基于医院的开放标签多中心平行组随机对照试验，采用区组随机化并按1:1比例分配治疗，在印度东部的一家二级医院和一家三级医院招募了286名妊娠14至24周、血红蛋白水平<11 g/dl且拥有智能手机的贫血孕妇。实验组通过结构化文本提醒、WhatsApp语音消息和电话接受为期一个月的电话干预。对照组给予标准治疗疗程。
结果
286名女性（n = 143，n = 143）被随机分组，36人失访，剩余250人进行分析（n = 123，n = 127），实验组的依从性提高了44.9%，对照组提高了13.8%（P < 0.001）。不依从的主要原因是遗忘（24%）、恶心和呕吐（23.2%）以及便秘（18.8%）。实验组血红蛋白水平升高了0.8 g/dl（P < 0.001），对照组升高了0.2 g/dl（P < 0.807）。
结论
电话干预除了提高口服IFAS的依从性外，还能减轻贫血孕妇的副作用并提高血红蛋白水平。实验组的依从性提高了三倍，而对照组仅有小幅提高。本研究建议实施电话干预以促进贫血孕妇对口服IFAS的依从性。
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