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

• DOI: 10.1093/ajcn/nqy228
• Publication Date: 2018-08-10T03:52:35Z
• Authors: 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 McClure; Nancy F Krebs
• Keywords: International Public Health; Adult; Asia; Adolescent; 610; Gestational Age; Fetal Development; 03 medical and health sciences; Maternal and Child Health; Pregnancy; birth length; Medicine and Health Sciences; Body Size; Humans; Developing Countries; Growth Disorders; 2. Zero hunger; 0303 health sciences; preconception; stunting; Infant, Newborn; Pregnancy Outcome; Maternal Nutritional Physiological Phenomena; Guatemala; 3. Good health; Original Research Communications; Dietary Supplements; Infant, Small for Gestational Age; Democratic Republic of the Congo; Premature Birth; lipid nutrient supplement; Female; pregnancy; Preconception Care

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