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一项在受孕前开始的多国随机对照临床试验:妇女优先试验。

A multicountry randomized controlled trial of comprehensive maternal nutrition supplementation initiated before conception: the Women First trial.

机构信息

Department of Pediatrics, Section of Nutrition, University of Colorado Anschutz Medical Campus, Aurora, CO.

INCAP (Instituto de Nutrición de Centro América y Panamá), Guatemala City, Guatemala.

出版信息

Am J Clin Nutr. 2019 Feb 1;109(2):457-469. doi: 10.1093/ajcn/nqy228.

DOI:10.1093/ajcn/nqy228
PMID:30721941
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6367966/
Abstract

BACKGROUND

Reported benefits of maternal nutrition supplements commenced during pregnancy in low-resource populations have typically been quite limited.

OBJECTIVES

This study tested the effects on newborn size, especially length, of commencing nutrition supplements for women in low-resource populations ≥3 mo before conception (Arm 1), compared with the same supplement commenced late in the first trimester of pregnancy (Arm 2) or not at all (control Arm 3).

METHODS

Women First was a 3-arm individualized randomized controlled trial (RCT). The intervention was a lipid-based micronutrient supplement; a protein-energy supplement was also provided if maternal body mass index (kg/m2) was <20 or gestational weight gain was less than recommendations. Study sites were in rural locations of the Democratic Republic of the Congo (DRC), Guatemala, India, and Pakistan. The primary outcome was length-for-age z score (LAZ), with all anthropometry obtained <48 h post delivery. Because gestational ages were unavailable in DRC, outcomes were determined for all 4 sites from WHO newborn standards (non-gestational-age-adjusted, NGAA) as well as INTERGROWTH-21st fetal standards (3 sites, gestational age-adjusted, GAA).

RESULTS

A total of 7387 nonpregnant women were randomly assigned, yielding 2451 births with NGAA primary outcomes and 1465 with GAA outcomes. Mean LAZ and other outcomes did not differ between Arm 1 and Arm 2 using either NGAA or GAA. Mean LAZ (NGAA) for Arm 1 was greater than for Arm 3 (effect size: +0.19; 95% CI: 0.08, 0.30, P = 0.0008). For GAA outcomes, rates of stunting and small-for-gestational-age were lower in Arm 1 than in Arm 3 (RR: 0.69; 95% CI: 0.49, 0.98, P = 0.0361 and RR: 0.78; 95% CI: 0.70, 0.88, P < 0.001, respectively). Rates of preterm birth did not differ among arms.

CONCLUSIONS

In low-resource populations, benefits on fetal growth-related birth outcomes were derived from nutrition supplements commenced before conception or late in the first trimester. This trial was registered at clinicaltrials.gov as NCT01883193.

摘要

背景

在资源匮乏的人群中,报告的母体营养补充对新生儿大小(尤其是长度)的益处通常非常有限。

目的

本研究测试了在资源匮乏的人群中,妇女在受孕前≥3 个月开始营养补充(第 1 组)与在妊娠早期第 1 个三个月末开始补充(第 2 组)或根本不补充(第 3 组)对新生儿大小的影响,特别是对长度的影响。

方法

妇女第一是一项 3 臂个体化随机对照试验(RCT)。干预措施是一种基于脂质的微量营养素补充剂;如果产妇的体重指数(kg/m2)<20 或体重增加不符合建议,则还提供蛋白质-能量补充剂。研究地点在刚果民主共和国(DRC)、危地马拉、印度和巴基斯坦的农村地区。主要结局是年龄别身长 Z 评分(LAZ),所有人体测量均在分娩后<48 小时内进行。由于在 DRC 无法获得胎龄,因此根据世卫组织新生儿标准(非胎龄调整,NGAA)和 INTERGROWTH-21 胎儿标准(3 个地点,胎龄调整,GAA)对所有 4 个地点的结果进行了确定。

结果

共有 7387 名非孕妇被随机分配,其中 2451 名分娩时采用 NGAA 主要结局,1465 名采用 GAA 结局。使用 NGAA 或 GAA 时,第 1 组和第 2 组的平均 LAZ 和其他结局均无差异。第 1 组的平均 LAZ(NGAA)大于第 3 组(效应大小:+0.19;95%CI:0.08,0.30,P=0.0008)。对于 GAA 结局,第 1 组的发育迟缓率和小于胎龄儿的发生率低于第 3 组(RR:0.69;95%CI:0.49,0.98,P=0.0361 和 RR:0.78;95%CI:0.70,0.88,P<0.001)。各组之间的早产率没有差异。

结论

在资源匮乏的人群中,从受孕前或妊娠早期开始的营养补充对与胎儿生长相关的出生结局有获益。本试验在 clinicaltrials.gov 注册为 NCT01883193。

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