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Table 2 Study outcomes, expected results and key indicators

From: 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

Study outcomes Expected result Key indicator
1a. Perinatal composite outcome (Main perinatal outcome) Reduction in the rate of the composite perinatal outcome among infants of women exposed to Mg++ vs. placebo Preterm birth < 37 weeks gestation, stillbirth > 20 weeks gestation, neonatal death < 28 days after birth, or SGA birthweight < 10 percentile
1b. Preterm birth (PTB) (Secondary objective) Reduction in the rate of PTB among infants of women exposed to Mg++ vs. placebo Birth at gestational age < 37 weeks
1c. Stillbirth (Secondary objective) Reduction in the rate of stillbirths among pregnant women exposed to Mg++ Fetal loss after 20 weeks gestation, in the absence of a major congenital anomaly evident at birth
1d. Small for gestational age birthweight < 10th percentile (Secondary objective) Reduction in the rate of SGA among infants of women exposed to Mg++ vs. placebo SGA detected by a birthweight < 10th percentile
1e. Neonatal death < 28 days after birth (Secondary objective) Reduction in the rate of neonatal death SGA among infants of women exposed to Mg++ vs. placebo Neonatal death of a liveborn infant from the date of birth up to and including 27 days after birth, in the absence of a major congenital anomaly evident at birth
1f. Neonatal intensive care unit (NICU) admission (Secondary objective) Reduction in the rate of NICU admission among infants of women exposed to Mg++ vs. placebo NICU admission < 28 days after birth
2a. Maternal composite outcome (Main maternal outcome) Reduction in the rate of the composite maternal outcome among women exposed to Mg++ vs. placebo Preeclampsia or eclampsia < 37 weeks gestation, severe gestational hypertension < 37 weeks gestation, placental abruption in pregnancy, or maternal stroke or death during pregnancy or ≤ 7 days after delivery
2b. Preeclampsia and eclampsia < 37 weeks gestation (Secondary objective) Reduction in rate of preterm preeclampsia or eclampsia among pregnant women exposed to Mg++ vs. placebo Increased blood pressure > 140/90 mm Hg associated with ≥ 2 proteinuria, and/or seizures, and/or the HELLP Syndrome, arising < 37 weeks gestation
2c. Severe non-proteinuric hypertension < 37 weeks gestation (Secondary objective) Reduction in rate of preterm severe non-proteinuric hypertension among pregnant women exposed to Mg++ vs. placebo Increased systolic blood pressure > 160 mm Hg or diastolic blood pressure > 105 mm Hg, with ≤ 1+ proteinuria, arising < 37 weeks gestation
2d. Maternal stroke (Secondary objective) Reduction in rate of maternal stroke among pregnant women exposed to Mg++ vs. placebo Abrupt onset of a focal neurological deficit in the distribution of a brain artery persisting more than 24 hours due to intracerebral hemorrhage or ischemic infarction, arising during pregnancy or ≤ 7 days after delivery
2d. Maternal intensive care unit (ICU) admission (Secondary objective) Reduction in the rate of maternal ICU admission among women exposed to Mg++ vs. placebo Adult ICU admission during pregnancy or ≤ 7 days after delivery