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

K. Michael Hambidge, Jamie E. Westcott, Ana Garcés, Lester Figueroa, Shivaprasad S. Goudar, Sangappa M. Dhaded, Omrana Pasha, Sumera A. Ali, Antoinette Tshefu, Adrien Lokangaka, Richard J. Derman, Robert L. Goldenberg, Carl L. Bose, Melissa Bauserman, Marion Koso-Thomas, Vanessa R. Thorsten, Amaanti Sridhar, Kristen Stolka, Abhik Das, Elizabeth M. McClureNancy F. Krebs

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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
Publication statusPublished - Feb 1 2019

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Keywords

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

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Nutrition and Dietetics

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