BRAzil magnesium (BRAMAG) trial: a double-masked randomized clinical trial of oral magnesium supplementation in pregnancy
de Araújo CAL, Ray JG, Figueiroa JN, Alves JG
BMC pregnancy and childbirth · 16 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
- Subvenciones
- Bill and Melinda Gates Foundation (OPP1107597); Conselho Nacional de Desenvolvimento Científico e Tecnológico (401609/2013-8); Conselho Nacional de Desenvolvimento Científico e Tecnológico (2013-8)
Según 2 financiadores declarados y la declaración de financiación del texto completo.
Publicación
- Publicado
- 2020-04-21 · BMC Pregnancy Childbirth · vol. 20 · número 1 · pág. 234
- Editorial
- BioMed Central
- Citado
- 24 citas · más que el 87% de estudios similares · 1.9× el promedio de su campo
- Referencias
- 38 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, Placental abruption, Placebo, Obstetrics, Preeclampsia, Gestation, Randomized controlled trial, Small for gestational age, Gestational hypertension, Eclampsia, Gestational age, Internal medicine
- MeSH
- humans, pregnancy complications, hypertension, pregnancy-induced, pre-eclampsia, abruptio placentae, premature birth, magnesium, citric acid, organometallic compounds, administration, oral, double-blind method, gestational age, pregnancy, dietary supplements, adolescent, adult, middle aged, infant, newborn, infant, small for gestational age, brazil, female, stillbirth, young adult
4 autores
- Carla Adriane Leal de Araújo🇧🇷Faculdade Frassinetti do Recife; Instituto de Medicina Integral Professor Fernando Figueira; Faculdade Pernambucana de Saúde
- Joel Geoffrey Ray🇨🇦🇬🇧 · autor de correspondenciaSt. Michael's Hospital; University of Toronto; St Michael's Hospital
- José Natal Figueirôa🇧🇷Instituto de Medicina Integral Professor Fernando Figueira
- João Guilherme Bezerra Alves🇧🇷Instituto de Medicina Integral Professor Fernando Figueira
Resumen
El texto original del estudio, en el idioma en que se publicó.
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 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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
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