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临床试验/NCT04559711
NCT04559711Unknown不适用

Demonstration Programme to Improve Maternal Nutrition Service Delivery Including Multiple Micronutrient Supplementation (MMS) Through Public Health ANC Platforms: A Community Based Cluster Randomized Control Trial

International Centre for Diarrhoeal Disease Research, Bangladesh1 个研究点 分布在 1 个国家目标入组 2,520 人开始时间: 2020年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
2,520
试验地点
1
主要终点
Changes in the coverage of 100+ MMS supplementation among recently delivered women who received 4 ANC from the baseline to the end of the project in the intervention and the comparison areas

研究概览

简要总结

Malnutrition among women of reproductive age is a significant public health problem in Bangladesh, with major implications for a woman's own health and that of her newborn child. The principal drivers for maternal malnutrition in Bangladesh are poor-quality diets, care seeking practices and access to health care. An ideal contact point for pregnant women are antenatal care visits (ANC). However, the provision of maternal nutrition services through government systems is inadequate with just 29% of pregnant women attending all 4 ANC visits and 18% of women consuming at least 100 IFA tablets. Moreover, WHO made a context specific recommendation that countries with a high prevalence of nutritional deficiencies may choose to adopt multiple micronutrient supplementation (MMS) over iron folic acid (IFA). The health benefits of MMS cannot be harnessed without a properly functioning delivery platform. A multifaceted approach focusing on improving the quality of ANC, the supply system for these services, engagement with communities, in addition to the adoption of MMS may have large benefits to women and children in Bangladesh. UNICEF and the Bill and Melinda Gates Foundation have partnered with several different organizations, including the GoB, Sight & Life, Pennsylvania State University (PSU) and icddr, b to design and assess outcome of a community based randomized control trial to improve coverage and quality of maternal nutrition service delivery through ANC platform. The investigators hypothesize that implementation of demonstration programme will result in 60% relative improvement in the coverage of 100+ MMS among women who received 4+ANC in the intervention areas compared to the coverage of 100+ IFA among women who received 4+ANC in comparison areas.

详细描述

  1. Burden:

Globally, it is recognized that pre-conception and during pregnancy malnutrition among women is an underlying cause of maternal morbidity, mortality, and poor birth outcomes including low birth weight babies. In Bangladesh, the poor pre-conception and pregnancy nutritional status of women contributes to the prevailing high rates of low birth weight among newborns. Each year, approximately 860,000 or 28% of babies are born with low birth weight (<2500g) greatly increasing their risk of stunting and wasting, and diet-related non-communicable diseases in adult life. 2. Knowledge gap:

An ideal contact point for pregnant women for delivering nutrition services are antenatal care visits (ANC). However, the provision of maternal nutrition services through government systems is inadequate in terms of coverage and quality. Overall 29% of pregnant women in Bangladesh receive 4 ANC and 18% of women consume at least 100 IFA tablets. Moreover recent WHO context specific recommendation suggest countries with a high prevalence of nutritional deficiencies may choose to adopt multiple micronutrient supplementation (MMS) over iron folic acid (IFA). The health benefits of MMS cannot be harnessed without a properly functioning delivery platform. A multifaceted approach focusing on improving the quality of ANC, the supply system for these services, engagement with communities, in addition to the adoption of MMS may have large benefits to women and children in Bangladesh. UNICEF and the Bill and Melinda Gates Foundation have partnered with several different organizations, including the GoB and icddr, b to build a comprehensive understanding of where gaps in ANC and nutritional care delivery currently exist, how to bridge these gaps, strengthen both the supply and service system, engage with a larger number of pregnant women, and finally encourage the adoption of the programme across Bangladesh. 3. Relevance:

The most recent State of Food Security and Nutrition in Bangladesh Report found that 66% of women did not consume adequately diversified diets, indicating micronutrient deficiencies. A growing body of evidence has found that multiple micronutrient supplementation (MMS) may result in better neonatal outcomes for undernourished pregnant women. MMS has been associated with reductions in the number of LBW and small for gestational age (SGA) births, as well as a reduction in the number of preterm births among mothers who were underweight in both meta-analysis and a randomized control trial in Bangladesh. Recently in Dhaka, Bangladesh national anaemia consultation workshop was held, which also recommended changing the formulation from IFA only to a multi-micronutrient supplement for pregnant women and to scale up providing children with MNPs.

Objectives:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Pregnant women coming for ANC in the public health facilities
  • •Provide consent to participate in the study

排除标准

  • •pregnant women who will not provide consent to participate in the study

研究组 & 干预措施

Intervention arm

Experimental

Strengthening coverage and quality of nutrition services including MMS during ANC

干预措施: Strengthening coverage and quality of nutrition services during ANC (Other)

Comparison arm

No Intervention

Existing provision of nutrition services during ANC.

结局指标

主要结局

Changes in the coverage of 100+ MMS supplementation among recently delivered women who received 4 ANC from the baseline to the end of the project in the intervention and the comparison areas

时间窗: Baseline (0 months) and end of project (18 months)

Change in the proportion of pregnant women received at least 4 ANCs and consumed 100+ MMS supplementation in their last pregnancy from baseline to the end of the project in intervention and comparison areas

次要结局

  • Change in the quality of nutrition services during ANC (4 ANC MMS/IFA, weight gain monitoring and dietary counseling) from the baseline to the end of the project in the intervention and the comparison areas(Baseline (0 months) and end of project(18 months))
  • Change in the coverage of nutrition counselling from the baseline to the end of the project in the intervention and the comparison areas(Baseline (0 months) and end of project(18 months))
  • Change in the coverage of weight monitoring from the baseline to the end of the project in the intervention and the comparison areas(Baseline (0 months) and end of project(18 months))
  • Change in the coverage of 4+ ANC from the baseline to the end of the project in the intervention and the comparison areas(Baseline (0 months) and end of project(18 months))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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