Antenatal magnesium sulphate for the prevention of cerebral palsy in infants born preterm: a double-blind, randomised, placebo-controlled, multi-centre trial
Research output: Contribution to journal › Journal article › Research › peer-review
OBJECTIVE: To study the effect of antenatal magnesium sulphate (MgSO4 ) on cerebral palsy (CP) in a manner that also provides adequate power for a linked trial sequential analysis.
DESIGN: Double-blind, randomised, placebo-controlled, multi-centre trial.
SETTING: Fourteen Danish obstetric departments.
POPULATION: In total, 560 pregnant women at risk for preterm delivery before 32 weeks of gestation were randomised from December 2011 to January 2018. Those women gave birth to 680 children.
METHODS: Women were randomised to receive either a loading dose of 5 g MgSO4 followed by 1 g/hour or a placebo in identical volumes. The children were followed up at a corrected age of 18 months or older with a review of their medical charts and with the Ages and Stages Questionnaire.
MAIN OUTCOME MEASURE: The primary outcome measure was moderate to severe CP. Secondary outcomes included mortality, neonatal morbidity, blindness and mild CP.
RESULTS: The crude rates of moderate to severe CP in the MgSO4 group and the placebo group were 2.0% and 3.3%, respectively. The adjusted odds of moderate to severe CP were lower in the MgSO4 group than in the placebo group (odds ratio 0.61; 95% CI 0.23-1.65).
CONCLUSIONS: Antenatal MgSO4 before 32 weeks of gestation decreases the likelihood of moderate to severe CP; these results are entirely consistent with other randomised evidence summarised in the linked trial sequential analysis.
TWEETABLE ABSTRACT: Antenatal magnesium sulphate may decrease the risk of moderate to severe cerebral palsy in children born before 32 weeks of gestation.
Original language | English |
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Journal | B J O G |
Volume | 127 |
Issue number | 10 |
Pages (from-to) | 1217-1225 |
Number of pages | 9 |
ISSN | 1470-0328 |
DOIs | |
Publication status | Published - Sep 2020 |
- Adult, Cerebral Palsy/prevention & control, Denmark, Double-Blind Method, Female, Humans, Infant, Infant, Newborn, Magnesium Sulfate/administration & dosage, Neuroprotective Agents/administration & dosage, Pregnancy, Premature Birth/drug therapy, Prenatal Care/methods, Severity of Illness Index
Research areas
ID: 250867666