ABSTRACT
BACKGROUND: There is conflicting evidence about the role of oral magnesium supplementation in the prevention of preterm birth and related adverse outcomes. The objective of this study was to compare magnesium citrate with placebo in the prevention of adverse perinatal and maternal outcomes among women at higher risk. METHODS: This multicenter, double-masked, placebo-controlled randomized superiority clinical trial compared oral magnesium citrate 300 mg to matched placebo, from 12 to 20 weeks' gestation until delivery. This trial was completed in three centers in northeastern Brazil. Eligible women were those with a singleton pregnancy and ≥ 1 risk factor, such as prior preterm birth or preeclampsia, or current chronic hypertension or pre-pregnancy diabetes mellitus, age > 35 years or elevated body mass index. The primary perinatal composite outcome comprised preterm birth < 37 weeks' gestation, stillbirth > 20 weeks, neonatal death or NICU admission < 28 days after birth, or small for gestational age birthweight < 3rd percentile. The co-primary maternal composite outcome comprised preeclampsia or eclampsia < 37 weeks, severe gestational hypertension < 37 weeks, placental abruption, or maternal stroke or death during pregnancy or ≤ 7 days after delivery. RESULTS: Analyses comprised 407 women who received magnesium citrate and 422 who received placebo. The perinatal composite outcome occurred among 75 (18.4%) in the magnesium arm and 76 (18.0%) in the placebo group - an adjusted odds ratio (aOR) of 1.10 (95% CI 0.72-1.68). The maternal composite outcome occurred among 49 (12.0%) women in the magnesium arm and 41 women (9.7%) in the placebo group - an aOR of 1.29 (95% CI 0.83-2.00). CONCLUSIONS: Oral magnesium citrate supplementation did not appear to reduce adverse perinatal or maternal outcomes in high-risk singleton pregnancies. TRIAL REGISTRATION: ClinicalTrials.gov NCT02032186, registered January 9, 2014.
Subject(s)
Citric Acid/administration & dosage , Organometallic Compounds/administration & dosage , Premature Birth/epidemiology , Abruptio Placentae/epidemiology , Administration, Oral , Adolescent , Adult , Brazil/epidemiology , Dietary Supplements , Double-Blind Method , Female , Gestational Age , Humans , Hypertension, Pregnancy-Induced/epidemiology , Infant, Newborn , Infant, Small for Gestational Age , Magnesium , Middle Aged , Pre-Eclampsia/epidemiology , Pregnancy , Pregnancy Complications/epidemiology , Stillbirth , Young AdultABSTRACT
Some studies have suggested that abdominal visceral adipose tissue depth (VAD) measured by ultrasound in early pregnancy, may predict the future onset of gestational diabetes mellitus (GDM). Wheter this is true, independent of pre-pregnancy body mass index (BMI), has been debated, leading the current study. A prospective cohort study was completed, in which VAD was measured at around 14 weeks' gestation. GDM was later assessed by an oral glucose tolerance test at 24 to 28 weeks, according to the IADPSG criteria. Logistic regression analysis and receiver operating curve (ROC) analysis were used to estimate the predictive value of VAD, above and beyond pre-pregnancy BMI. 627 pregnant women were enrolled, and 518 completed the study. VAD was measured at a mean of 14.4 weeks' gestation. 87 women (16.8%) subsequently developed GDM. The unadjusted odds ratio (OR) for developing GDM was 1.99 (95% CI 1.59-2.46) per 1-cm increase in VAD. After adjusting for maternal BMI and age, the OR was 2.00 (95% CI 1.61 to 2.50). The ROC under the curve for developing GDM was higher for VAD (0.70, 95% CI 0.63 to 0.75) than for pre-pregnancy BMI (0.57 95% CI 0.50 to 0.64) (p < 0.001). In conclusion, higher VAD may better predict GDM than pre-pregnancy BMI.