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
Alves JG, de Araújo CA, Pontes IE, Guimarães AC, Ray JG
BMC pregnancy and childbirth · 15 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación independiente
- Organización sin fines de lucro
- Bill and Melinda Gates Foundation
- Gobierno
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Gobierno
- Canadian Institutes of Health Research
Según 3 financiadores declarados y la declaración de financiación del texto completo.
Publicación
- Publicado
- 2014-07-08 · BMC Pregnancy Childbirth · vol. 14 · número 1 · pág. 222
- Editorial
- BioMed Central
- Citado
- 20 citas · más que el 64% de estudios similares · 0.4× el promedio de su campo
- Referencias
- 49 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY
- Áreas de investigación
- Preterm Birth and Chorioamnionitis · Pregnancy and preeclampsia studies · Magnesium in Health and Disease
- Palabras clave
- Medicine, Pregnancy, Obstetrics, Gestation, Preeclampsia, Placental abruption, Randomized controlled trial, Premature birth, Internal medicine
- MeSH
- humans, pregnancy complications, pre-eclampsia, abruptio placentae, premature birth, magnesium deficiency, citric acid, organometallic compounds, administration, oral, double-blind method, pregnancy, research design, dietary supplements, adolescent, adult, middle aged, infant, infant, newborn, infant, small for gestational age, brazil, female, stillbirth, stroke, young adult, maternal death, infant death
5 autores
- João Guilherme Bezerra Alves🇧🇷Instituto de Medicina Integral Professor Fernando Figueira
- Carla Adriane Fonseca Leal de Araújo🇧🇷Instituto de Medicina Integral Professor Fernando Figueira
- Isabelle E A Pontes🇧🇷Instituto de Medicina Integral Professor Fernando Figueira
- Angélica Guimarães
- Joel Geoffrey Ray🇨🇦🇬🇧 · autor de correspondenciaSt. Michael's Hospital; St Michael's Hospital
Resumen
El texto original del estudio, en el idioma en que se publicó.
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/design
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 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.
Discussion
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.
Trial registration
ClinicalTrials.gov Identifier NCT02032186, registered December 19, 2013.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
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