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Magnesium sulphate given before very-preterm birth to protect infant brain: the randomised controlled PREMAG trial†

  1. S Marret1,*,
  2. L Marpeau2,
  3. V Zupan-Simunek3,
  4. D Eurin4,
  5. C Lévêque5,
  6. M-F Hellot6,
  7. J Bénichou7,
  8. PREMAG trial group1

Article first published online: 4 DEC 2006

DOI: 10.1111/j.1471-0528.2006.01162.x

Issue

BJOG: An International Journal of Obstetrics & Gynaecology

BJOG: An International Journal of Obstetrics & Gynaecology

Volume 114, Issue 3, pages 310–318, March 2007

Additional Information

How to Cite

Marret, S., Marpeau, L., Zupan-Simunek, V., Eurin, D., Lévêque, C., Hellot, M.-F., Bénichou, J. and PREMAG trial group (2007), Magnesium sulphate given before very-preterm birth to protect infant brain: the randomised controlled PREMAG trial. BJOG: An International Journal of Obstetrics & Gynaecology, 114: 310–318. doi: 10.1111/j.1471-0528.2006.01162.x

Author Information

  1. 1

    Department of Neonatal Medicine

  2. 2

    Department of Obstetrics and Gynaecology, Rouen University Hospital, Rouen, France

  3. 3

    Department of Neonatal Medicine, Antoine-Béclère University Hospital, Clamart, France

  4. 4

    Department of Radiopediatrics

  5. 5

    Department of Neonatal Medicine

  6. 6

    Department of Biostatistics, Rouen University Hospital, Rouen, France

  7. 7

    Department of Biostatistics, Rouen University Hospital and INSERM U657, Rouen, France

*Dr S Marret, Department of Neonatal Medicine, Rouen University Hospital, 1, rue de Germont, 76031 Rouen Cedex, France. Email stephane.marret@chu-rouen.fr

  • †

    A complete list of the members of the PREMAG trial is given in the ‡.

Publication History

  1. Issue published online: 4 DEC 2006
  2. Article first published online: 4 DEC 2006
  3. Accepted 21 September 2006. Published OnlineEarly 24 November 2006.

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Keywords:

  • Mortality;
  • neuroprotection;
  • newborn;
  • periventricular;
  • leucomalacia;
  • white matter

Objective  To evaluate whether magnesium sulphate (MgSO4) given to women at risk of very-preterm birth would be neuroprotective in preterm newborns and would prevent neonatal mortality and severe white-matter injury (WMI).

Design  A randomised study.

Setting  Eighteen French tertiary hospitals.

Population  Women with fetuses of gestational age < 33 weeks whose birth was planned or expected within 24 hours were enrolled from July 1997 to July 2003 with follow up of infants until hospital discharge.

Methods  Five hundred and seventy-three mothers were randomly assigned to receive a single 40-ml infusion of 0.1 g/ml of MgSO4 (4 g) solution or isotonic 0.9% saline (placebo) over 30 minutes. This study is registered as an International Standard Randomised Controlled Trial, number 00120588.

Main outcome measures  The primary endpoints were rates of severe WMI or total mortality before hospital discharge, and their combined outcome. Analyses were based on intention to treat.

Results  After 6 years of enrolment, the trial was stopped. Data from 688 infants were analysed. Comparing infants who received MgSO4 or placebo, respectively, total mortality (9.4 versus 10.4%; OR: 0.79, 95% CI 0.44–1.44), severe WMI (10.0 versus 11.7%; OR: 0.78, 95% CI 0.47–1.31) and their combined outcomes (16.5 versus 17.9%; OR: 0.86, 95% CI 0.55–1.34) were less frequent for the former, but these differences were not statistically significant. No major maternal adverse effects were observed in the MgSO4 group.

Conclusion  Although our results are inconclusive, improvements of neonatal outcome obtained with MgSO4 are of potential clinical significance. More research is needed to assess the protective effect of MgSO4 alone or in combination with other neuroprotective molecules.

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