Institute for Global Health, University College London, London, UK
HERD International, Kathmandu, Nepal.
BMJ Open. 2023 Feb 16;13(2):e064709. doi: 10.1136/bmjopen-2022-064709.
Despite evidence that iron and folic acid (IFA) supplements can improve anaemia in pregnant women, uptake in Nepal is suboptimal. We hypothesised that providing virtual counselling twice in mid-pregnancy, would increase compliance to IFA tablets during the COVID-19 pandemic compared with antenatal care (ANC alone.
This non-blinded individually randomised controlled trial in the plains of Nepal has two study arms: (1) control: routine ANC; and (2) 'Virtual' antenatal counselling plus routine ANC. Pregnant women are eligible to enrol if they are married, aged 13-49 years, able to respond to questions, 12-28 weeks' gestation, and plan to reside in Nepal for the next 5 weeks. The intervention comprises two virtual counselling sessions facilitated by auxiliary nurse midwives at least 2 weeks apart in mid-pregnancy. Virtual counselling uses a dialogical problem-solving approach with pregnant women and their families. We randomised 150 pregnant women to each arm, stratifying by primigravida/multigravida and IFA consumption at baseline, providing 80% power to detect a 15% absolute difference in primary outcome assuming 67% prevalence in control arm and 10% loss-to-follow-up. Outcomes are measured 49-70 days after enrolment, or up to delivery otherwise.
consumption of IFA on at least 80% of the previous 14 days.
dietary diversity, consumption of intervention-promoted foods, practicing ways to enhance bioavailability and knowledge of iron-rich foods. Our mixed-methods process evaluation explores acceptability, fidelity, feasibility, coverage (equity and reach), sustainability and pathways to impact. We estimate costs and cost-effectiveness of the intervention from a provider perspective. Primary analysis is by intention-to-treat, using logistic regression.
We obtained ethical approval from Nepal Health Research Council (570/2021) and UCL ethics committee (14301/001). We will disseminate findings in peer-reviewed journal articles and by engaging policymakers in Nepal.
ISRCTN17842200.
尽管有证据表明铁和叶酸（IFA）补充剂可以改善孕妇贫血，但尼泊尔的摄入量并不理想。我们假设在 COVID-19 大流行期间，与产前护理（ANC）相比，为孕妇提供两次中期虚拟咨询，将增加 IFA 片的依从性。
这是尼泊尔平原地区的一项非盲个体随机对照试验，有两个研究组：（1）对照组：常规 ANC；（2）“虚拟”产前咨询加常规 ANC。如果孕妇已婚、年龄在 13-49 岁之间、能够回答问题、妊娠 12-28 周、并计划在接下来的 5 周内在尼泊尔居住，则有资格参加。干预措施包括两次由辅助护士助产士在妊娠中期至少相隔 2 周进行的虚拟咨询。虚拟咨询采用与孕妇及其家庭对话式解决问题的方法。我们将 150 名孕妇随机分配到每个组中，按初产妇/多产妇和基线时 IFA 的使用情况进行分层，假设对照组的患病率为 67%，失访率为 10%，则提供 80%的功效来检测主要结局的 15%绝对差异。结果在入组后 49-70 天测量，否则直到分娩。
在过去 14 天的至少 80%时间内服用 IFA。
饮食多样性、干预促进食物的摄入、实践增强生物利用度的方法以及富含铁的食物的知识。我们的混合方法过程评估探索了可接受性、保真度、可行性、覆盖率（公平性和可达性）、可持续性和影响途径。我们从提供者的角度估计干预的成本和成本效益。主要分析采用意向治疗，使用逻辑回归。
我们从尼泊尔健康研究委员会（570/2021）和 UCL 伦理委员会（14301/001）获得了伦理批准。我们将通过在同行评议的期刊文章中发表和与尼泊尔的政策制定者接触来传播研究结果。
ISRCTN17842200。
