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

on behalf of the Women First Preconception Trial Study Group

Research output: Contribution to journalArticlepeer-review

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/m 2) 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.

Original languageEnglish (US)
Pages (from-to)457-469
Number of pages13
JournalAmerican Journal of Clinical Nutrition
Volume109
Issue number2
DOIs
StatePublished - Feb 1 2019

Keywords

  • birth length
  • lipid nutrient supplement
  • preconception
  • pregnancy
  • stunting

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Nutrition and Dietetics

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