CompletedPhase 3ACTRN12606000252516

Australasian Collaborative Trial of Magnesium Sulphate for the Prevention of Mortality and Cerebral Palsy in Infants Born Very Preterm.


Sponsor

Prof Caroline Crowther

Enrollment

1,178 participants

Start Date

Feb 29, 1996

Study Type

Interventional

Conditions

Summary

Infants born preterm have an increased risk of mortality and cerebral palsy. Evidence from recent case controlled studies support animal research that suggests maternal administration of magnesium sulphate may reduce the risk of cerebral palsy and mortality in infants born very preterm. It is important that these findings are tested in large randomised controlled trials as soon as possible to assess whether prophylactic treatment should be recommedned for clinical practice in the case of women who are at risk of preterm delivery. Trial participants, trial research staff and all involved in clinical care of participants were blinded. Trial treatment packs of identical appearance, labelled only with unique study number.


Eligibility

Sex: FemalesMin Age: 16 YearssMax Age: 50 Yearss

Inclusion Criteria1

  • Pregnant women <30 weeks where delivery is planned or definately expected within 24 hours.

Exclusion Criteria1

  • Contraindications to magnesium sulphate; in second stage of labour; previous magnesium sulphate therapy in the pregnancy and magnesium sulphate therapy considered essential

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Interventions

Treatment group: Magnesium sulphate (2mmol/mL). Dosing regimen for both groups: Loading infusion: 8 mLs over 20mins via infusion pump. Maintenance: 2mLs/hr until delivery or 24 hrs whichever is longe

Treatment group: Magnesium sulphate (2mmol/mL). Dosing regimen for both groups: Loading infusion: 8 mLs over 20mins via infusion pump. Maintenance: 2mLs/hr until delivery or 24 hrs whichever is longer


Locations(1)

New Zealand

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ACTRN12606000252516