Rationale, design, methodology and sample characteristics for the Vietnam pre-conceptual micronutrient supplementation trial (PRECONCEPT): a randomized controlled study.
Rationale, design, methodology and sample characteristics for the Vietnam pre-conceptual micronutrient supplementation trial (PRECONCEPT): a randomized controlled study.
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DOI：
10.1186/1471-2458-12-898
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发表时间：
2012-10-24
影响因子：
4.5
通讯作者：
Ramakrishnan U
中科院分区：
文献类型：
--
作者：
Nguyen PH;Lowe AE;Martorell R;Nguyen H;Pham H;Nguyen S;Harding KB;Neufeld LM;Reinhart GA;Ramakrishnan U
在许多发展中国家，低出生体重和产妇贫血仍然是棘手的问题。目前仅在怀孕期间提供叶酸(IFA)补充剂的战略是否充分受到了质疑，因为许多妇女在怀孕时铁储备不足，母体和胎儿组织对微量营养素的大量需求，以及与产前护理的时间和覆盖范围有关的方案问题。育龄妇女每周补充IFA(WRA)可在短期内改善铁状况并减轻贫血负担，但很少有研究评估随后的怀孕和分娩结果。这项孕前试验旨在确定，与目前仅补充产前IFA的做法相比，孕前每周补充IFA或补充多种微量营养素(MM)是否会改善分娩结局和母婴铁状况。本文从基线调查数据和关键经验教训出发，概述了研究设计、方法和样本特征。我们在越南农村地区进行了一项双盲分层随机对照试验，招募了5011名妇女妇女，并随机分配他们接受每周补充剂，其中包括：1)2800μg叶酸；2)60 mg铁和2800μg叶酸或3)MM。怀孕的妇女每天接受IFA，并在怀孕、分娩和产后最多三个月进行跟踪。研究结果包括出生结果和母婴铁状况。正在收集关于家庭特征、产妇饮食和心理健康、人体测量、婴儿喂养做法、发病率和遵从性的数据。这项研究是及时的，是对世卫组织全球专家咨询的回应，该咨询确定了评估每周补充IFA和MM在WRA中的长期益处的必要性。研究结果将产生新的信息，以帮助指导旨在减轻妇女和儿童贫血负担并改善资源匮乏环境中的孕产妇和儿童健康结果的政策和方案。NCT01665378
Low birth weight and maternal anemia remain intractable problems in many developing countries. The adequacy of the current strategy of providing iron-folic acid (IFA) supplements only during pregnancy has been questioned given many women enter pregnancy with poor iron stores, the substantial micronutrient demand by maternal and fetal tissues, and programmatic issues related to timing and coverage of prenatal care. Weekly IFA supplementation for women of reproductive age (WRA) improves iron status and reduces the burden of anemia in the short term, but few studies have evaluated subsequent pregnancy and birth outcomes. The Preconcept trial aims to determine whether pre-pregnancy weekly IFA or multiple micronutrient (MM) supplementation will improve birth outcomes and maternal and infant iron status compared to the current practice of prenatal IFA supplementation only. This paper provides an overview of study design, methodology and sample characteristics from baseline survey data and key lessons learned. We have recruited 5011 WRA in a double-blind stratified randomized controlled trial in rural Vietnam and randomly assigned them to receive weekly supplements containing either: 1) 2800 μg folic acid 2) 60 mg iron and 2800 μg folic acid or 3) MM. Women who become pregnant receive daily IFA, and are being followed through pregnancy, delivery, and up to three months post-partum. Study outcomes include birth outcomes and maternal and infant iron status. Data are being collected on household characteristics, maternal diet and mental health, anthropometry, infant feeding practices, morbidity and compliance. The study is timely and responds to the WHO Global Expert Consultation which identified the need to evaluate the long term benefits of weekly IFA and MM supplementation in WRA. Findings will generate new information to help guide policy and programs designed to reduce the burden of anemia in women and children and improve maternal and child health outcomes in resource poor settings. NCT01665378
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影响因子：
1.9
作者：
Fall CH;Fisher DJ;Osmond C;Margetts BM;Maternal Micronutrient Supplementation Study Group
通讯作者：
Maternal Micronutrient Supplementation Study Group
影响因子：
4.2
作者：
Erhardt, JG;Estes, JE;Craft, NE
通讯作者：
Craft, NE
影响因子：
3.9
作者：
Adank, C;Green, TJ;Briars, B
通讯作者：
Briars, B
影响因子：
10.5
作者：
COX, JL;HOLDEN, JM;SAGOVSKY, R
通讯作者：
SAGOVSKY, R