None listed
Conditions
Brief 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.
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 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).
Sponsors
University of Adelaide
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
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 criteria
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.
Outcome results
None listed