BRAzil magnesium (BRAMAG) trial: a double-masked randomized clinical trial of oral magnesium supplementation in pregnancy
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 a...
Main Authors: | , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
BMC
2020-04-01
|
Series: | BMC Pregnancy and Childbirth |
Subjects: | |
Online Access: | http://link.springer.com/article/10.1186/s12884-020-02935-7 |
id |
doaj-c0851cbc821e4da985a5ca90a160b64c |
---|---|
record_format |
Article |
spelling |
doaj-c0851cbc821e4da985a5ca90a160b64c2020-11-25T03:14:11ZengBMCBMC Pregnancy and Childbirth1471-23932020-04-012011710.1186/s12884-020-02935-7BRAzil magnesium (BRAMAG) trial: a double-masked randomized clinical trial of oral magnesium supplementation in pregnancyCarla Adriane Leal de Araújo0Joel Geoffrey Ray1José Natal Figueiroa2João Guilherme Alves3Department of Pediatrics, Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)Departments of Medicine and Obstetrics and Gynaecology, St. Michael’s Hospital, University of TorontoDepartment of Biostatistics, Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)Department of Pediatrics, Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)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.http://link.springer.com/article/10.1186/s12884-020-02935-7PregnancyPreterm birthNewbornMagnesiumRandomized clinical trialPreeclampsia |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Carla Adriane Leal de Araújo Joel Geoffrey Ray José Natal Figueiroa João Guilherme Alves |
spellingShingle |
Carla Adriane Leal de Araújo Joel Geoffrey Ray José Natal Figueiroa João Guilherme Alves BRAzil magnesium (BRAMAG) trial: a double-masked randomized clinical trial of oral magnesium supplementation in pregnancy BMC Pregnancy and Childbirth Pregnancy Preterm birth Newborn Magnesium Randomized clinical trial Preeclampsia |
author_facet |
Carla Adriane Leal de Araújo Joel Geoffrey Ray José Natal Figueiroa João Guilherme Alves |
author_sort |
Carla Adriane Leal de Araújo |
title |
BRAzil magnesium (BRAMAG) trial: a double-masked randomized clinical trial of oral magnesium supplementation in pregnancy |
title_short |
BRAzil magnesium (BRAMAG) trial: a double-masked randomized clinical trial of oral magnesium supplementation in pregnancy |
title_full |
BRAzil magnesium (BRAMAG) trial: a double-masked randomized clinical trial of oral magnesium supplementation in pregnancy |
title_fullStr |
BRAzil magnesium (BRAMAG) trial: a double-masked randomized clinical trial of oral magnesium supplementation in pregnancy |
title_full_unstemmed |
BRAzil magnesium (BRAMAG) trial: a double-masked randomized clinical trial of oral magnesium supplementation in pregnancy |
title_sort |
brazil magnesium (bramag) trial: a double-masked randomized clinical trial of oral magnesium supplementation in pregnancy |
publisher |
BMC |
series |
BMC Pregnancy and Childbirth |
issn |
1471-2393 |
publishDate |
2020-04-01 |
description |
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. |
topic |
Pregnancy Preterm birth Newborn Magnesium Randomized clinical trial Preeclampsia |
url |
http://link.springer.com/article/10.1186/s12884-020-02935-7 |
work_keys_str_mv |
AT carlaadrianelealdearaujo brazilmagnesiumbramagtrialadoublemaskedrandomizedclinicaltrialoforalmagnesiumsupplementationinpregnancy AT joelgeoffreyray brazilmagnesiumbramagtrialadoublemaskedrandomizedclinicaltrialoforalmagnesiumsupplementationinpregnancy AT josenatalfigueiroa brazilmagnesiumbramagtrialadoublemaskedrandomizedclinicaltrialoforalmagnesiumsupplementationinpregnancy AT joaoguilhermealves brazilmagnesiumbramagtrialadoublemaskedrandomizedclinicaltrialoforalmagnesiumsupplementationinpregnancy |
_version_ |
1724644100544659456 |