None listed
Conditions
Brief 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.
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 longer
Sponsors
Prof Caroline Crowther
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
16 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Pregnant women <30 weeks where delivery is planned or definately expected within 24 hours.
Exclusion criteria
Contraindications to magnesium sulphate; in second stage of labour; previous magnesium sulphate therapy in the pregnancy and magnesium sulphate therapy considered essential
Outcome results
None listed