CompletedPhase 3ACTRN12611000491965

MAGENTA - Magnesium Sulphate at 30 to 34 weeks' gestational age: Neuroprotection Trial

Does antenatal magnesium sulphate given to women at risk of imminent preterm birth (defined as planned or definitely expected in the next 24 hours) between 30 and 34 weeks' gestation reduce the risk of death or cerebral palsy in their children at 2 years corrected age? - a randomised controlled trial


Sponsor

University of Adelaide

Enrollment

1,676 participants

Start Date

Jan 31, 2012

Study Type

Interventional

Conditions

Summary

Antenatal magnesium sulphate is recommended prior to preterm birth at less than 30 weeks’ gestation for neuroprotection of the fetus. Whether there are benefits at later gestations is uncertain. The primary aim of this randomised placebo controlled trial is to assess whether giving magnesium sulphate compared with placebo to women immediately prior to preterm birth between 30 and 34 weeks' gestation reduces the risks of death or cerebral palsy in their children at 2 years' corrected age. years' corrected age.


Eligibility

Sex: FemalesMin Age: 16 YearssMax Age: 50 Yearss

Inclusion Criteria1

  • Women are eligible for the trial if they are at risk of preterm birth between 30 and 34 weeks’ gestation where birth is planned or definitely expected within 24 hours, have a singleton or twin pregnancy, no contraindications to the use of antenatal magnesium sulphate (myasthenia gravis, respiratory depression, hypotension, absent patellar reflexes or renal failure) and give informed, written consent.

Exclusion Criteria1

  • Women are not eligible if they have a higher-order multiple pregnancy, have already received antenatal magnesium sulphate or if magnesium sulphate therapy is considered essential for the treatment of pre-eclampsia.

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Interventions

Magnesium Sulphate (8% solution)- 50 ml infusion equivalent to 4g magnesium sulphate heptahydrate (16 mmol magnesium ions) administered through a dedicated intravenous line over 30 minutes. This is ad

Magnesium Sulphate (8% solution)- 50 ml infusion equivalent to 4g magnesium sulphate heptahydrate (16 mmol magnesium ions) administered through a dedicated intravenous line over 30 minutes. This is administered to women at risk of preterm birth between 30 and 34 weeks' gestation when birth is imminent (defined as planned or definitely expected in the next 24 hours).


Locations(1)

New Zealand

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