A multicountry randomized controlled trial of comprehensive maternal nutrition supplementation initiated before conception: the Women First trial. Issue 2 (5th February 2019)

• Record Type: Journal Article
• Authors: Hambidge, K Michael; Westcott, Jamie E; Garcés, Ana; Figueroa, Lester; Goudar, Shivaprasad S; Dhaded, Sangappa M; Pasha, Omrana; Ali, Sumera A; Tshefu, Antoinette; Lokangaka, Adrien; Derman, Richard J; Goldenberg, Robert L; Bose, Carl L; Bauserman, Melissa; Koso-Thomas, Marion; Thorsten, Vanessa R; Sridhar, Amaanti; Stolka, Kristen; Das, Abhik; McClure, Elizabeth M; Krebs, Nancy F
• Is Part Of: American journal of clinical nutrition. Volume 109:Issue 2(2019)
• Page Start: 457
• Page End: 469
• Publication Date: 2019-02-05
• Subjects: preconception -- pregnancy -- birth length -- stunting -- lipid nutrient supplement; Diet therapy -- Periodicals; Nutrition -- Periodicals; Dietetics -- Periodicals; 613.205
• DOI: 10.1093/ajcn/nqy228
• Languages: English
• ISSNs: 0002-9165

Abstract

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.