Abstract
BackgroundPreterm 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/DesignWe 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.DiscussionThe 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.Trial registrationClinicalTrials.gov Identifier NCT02032186, registered December 19, 2013.
Highlights
Preterm birth is the leading cause of infant mortality globally, including Brazil
In a population-based study 97,000 live born singleton infants born to nulliparous Swedish women, there was a pronounced association between the hypertensive disease of pregnancy and SGA, especially for preeclampsia resulting in preterm delivery ≤ 32 weeks (OR of SGA: 40.5, 95% CI 31.5-51.4) and at 33–36 weeks (OR of SGA: 17.4, 95% CI 15.7-19.3) [16]
In women with 1 or more risk factors for an adverse pregnancy outcome, to determine whether there is a reduction in the composite perinatal outcome – preterm birth before 37 weeks gestation, stillbirth after 20 weeks gestation, neonatal death before 28 days after birth, or SGA birthweight under the 3rd percentile – following the administration of oral Mg++ citrate 150 mg twice daily versus oral placebo twice daily
Summary
We expect that oral Mg++ citrate supplements will lower the risk of preterm birth, perinatal mortality and neonatal morbidity, SGA, and will positively impact on maternal morbidity and mortality. The intervention might save lives, but lower maternal and early childhood disability. Competing interests The authors declare that they have no competing interests. Authors’ contributions JGBA: study concept, drafting of manuscript, manuscript revision, approval of final version. JGR: study concept, drafting of manuscript, manuscript revision, approval of final version. CAFLA: study concept, approval of final version. IEAP: study concept, approval of final version. ACG: study concept, approval of final version
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