title: The BRAzil MAGnesium (BRAMAG) trial: a randomized clinical trial of oral magnesium supplementation in pregnancy for the prevention of preterm birth and perinatal and maternal morbidity.
abstract: BACKGROUND
  Preterm birth is the leading cause of infant mortality globally, including Brazil. We will evaluate whether oral magnesium citrate reduces the risk of placental dysfunction and its negative consequences for both the fetus and mother, which, in turn, should reduce the need for indicated preterm delivery.
  
  
  METHODS
  We will complete a multicenter, randomized double-blind clinical trial comparing oral magnesium citrate 150 mg twice daily (n = 2000 women) to matched placebo (n = 1000 women), starting at 121/7 to 206/7 weeks gestation and continued until delivery. We will include women at higher risk for placental dysfunction, based on clinical factors from a prior pregnancy (e.g., prior preterm delivery, stillbirth or preeclampsia) or the current pregnancy (e.g., chronic hypertension, pre-pregnancy diabetes mellitus, maternal age > 35 years or pre-pregnancy maternal body mass index > 30 kg/m2). The primary perinatal outcome is a composite of preterm birth < 37 weeks gestation, stillbirth > 20 weeks gestation, neonatal death < 28 days, or SGA birthweight < 3rd percentile. The primary composite maternal outcome is preeclampsia arising < 37 weeks gestation, severe non-proteinuric hypertension arising < 37 weeks gestation, placental abruption, maternal stroke during pregnancy or ≤ 7 days after delivery, or maternal death during pregnancy or ≤ 7 days after delivery.
  
  
  CONCLUSIONS
  The results of this randomized clinical trial may be especially relevant in low and middle income countries that have high rates of prematurity and limited resources for acute newborn and maternal care.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier NCT02032186, registered December 19, 2013.
authors.forename: Joao Guilherme B
authors.initials: JG
authors.lastname: Alves
authors.forename: Carla Adriane Fonseca Leal
authors.initials: CA
authors.lastname: de Araújo
authors.forename: Isabelle E A
authors.initials: IE
authors.lastname: Pontes
authors.forename: Angélica C
authors.initials: AC
authors.lastname: Guimarães
authors.affiliation: Departments of Medicine, Obstetrics and Health Policy Management Evaluation, University of Toronto, St, Michael's Hospital, 30 Bond Street, Toronto, ON M5B 1 W8, Canada. rayj@smh.ca.
authors.forename: Joel G
authors.initials: JG
authors.lastname: Ray
mesh_terms: D000037:Abruptio Placentae / Q000517:prevention & control; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D001938:Brazil; D019343:Citric Acid / Q000008:administration & dosage*; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D066088:Infant Death / Q000517:prevention & control; D007231:Infant, Newborn; D007236:Infant, Small for Gestational Age; D008275:Magnesium Deficiency / Q000517:prevention & control*; D063130:Maternal Death / Q000517:prevention & control; D008875:Middle Aged; D009942:Organometallic Compounds / Q000008:administration & dosage*; D011225:Pre-Eclampsia / Q000517:prevention & control; D011247:Pregnancy; D011248:Pregnancy Complications / Q000517:prevention & control*; D047928:Premature Birth / Q000517:prevention & control; D012107:Research Design; D050497:Stillbirth; D020521:Stroke / Q000517:prevention & control; D055815:Young Adult
chemical_list: D009942:Organometallic Compounds; D019343:Citric Acid; C110422:magnesium citrate