Abstract
BackgroundThe primary aim of this study is to assess, using individual participant data (IPD) meta-analysis, the effects of administration of antenatal magnesium sulphate given to women at risk of preterm birth on important clinical outcomes for their child such as death and neurosensory disability. The secondary aim is to determine whether treatment effects differ depending on important pre-specified participant and treatment characteristics, such as reasons at risk of preterm birth, gestational age, or type, dose and mode of administration of magnesium sulphate.MethodsDesignThe Antenatal Magnesium Individual Participant Data (IPD) International Collaboration: assessing the benefits for babies using the best level of evidence (AMICABLE) Group will perform an IPD meta-analysis to answer these important clinical questions.Setting/TimelineThe AMICABLE Group was formed in 2009 with data collection commencing late 2010.Inclusion CriteriaFive trials involving a total 6,145 babies are eligible for inclusion in the IPD meta-analysis.Primary study outcomesFor the infants/children: Death or cerebral palsy. For the women: Any severe maternal outcome potentially related to treatment (death, respiratory arrest or cardiac arrest).DiscussionResults are expected to be publicly available in 2012.
Highlights
The primary aim of this study is to assess, using individual participant data (IPD) meta-analysis, the effects of administration of antenatal magnesium sulphate given to women at risk of preterm birth on important clinical outcomes for their child such as death and neurosensory disability
Summary of the Cochrane systematic review The Cochrane systematic review assessing the use of magnesium sulphate for women at risk of preterm birth for neuroprotection of the fetus [38] includes five trials (6145 babies): two from the US; the MagNet Trial [39] and the Beam Trial [40], one from Australia and New Zealand; the ActoMgSo4 Trial [41], one from France; the PreMag Trial [42], and one that was worldwide, but predominantly from developing countries; the Magpie Trial [43]
The first four trials targeted women likely to give birth early and magnesium was used for neuroprotection, one study, the MagNet trial [39], had a tocolytic arm
Summary
The primary aim of this study is to assess, using individual participant data (IPD) meta-analysis, the effects of administration of antenatal magnesium sulphate given to women at risk of preterm birth on important clinical outcomes for their child such as death and neurosensory disability. The secondary aim is to determine whether treatment effects differ depending on important pre-specified participant and treatment characteristics, such as reasons at risk of preterm birth, gestational age, or type, dose and mode of administration of magnesium sulphate. Cerebral palsy is a term which includes a number of different diseases or conditions that can arise at any time during brain development. The cerebral palsies remain the most frequent cause of severe motor disability in childhood with a background prevalence of two per thousand live births [5]. Over 90% of affected children with cerebral palsy are expected to survive to 20 years of age [6], contributing substantially to the burden of illness into adulthood
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