Magpie Trial

Incomplete

Magpie Trial Follow-Up Study Collaborative Group. "The Magpie Trial: a randomised trial comparing magnesium sulphate with placebo for pre-eclampsia. Outcome for women at 2 years". BJOG: An International Journal of Obstetrics and Gynaecology. 2007. 114(3):300-309.
PubMed • Full text

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Clinical Question

In pregnant women with preeclampsia, does magnesium sulphate decrease maternal and neonatal mortality and morbidity when compared with placebo?

Bottom Line

Magnesium sulphate significantly decreases the risk of eclampsia in pregnant women with preeclampsia.

Major Points

Pre-eclampsia is a systemic disorder affecting 2-8% of pregnancies. Prior to the Magpie Trial, anticonvulsants had been used for many years to prevent the risk of seizure, with magnesium sulphate emerging as possibly the most effective.

Several small and large randomized trials in diabetics had previously suggested a sizable benefit of tight glycemic control in reducing cardiovascular risk. The ACCORD trial was the largest study of its kind and demonstrated that not only does euglycemia (ie, HbA1c <6%) not reduce cardiovascular risk, it also is associated with a trend towards increased mortality.

Design

• International, multi-centre, double-blind, parallel-group, randomized controlled trial
• N=10,141
  • Magnesium sulphate (n=5,071)
  • Placebo (n=5,070)
• Setting: 175 secondary and tertiary hospitals in 33 countries with overall coordination in Oxford, UK
• Enrollment: February to July 1998 (pilot), July 1998 to Nov 2001 (main trial)
• Mean follow-up:
• Analysis: Intention-to-treat
• Primary outcome:

Population

Inclusion Criteria

• Not yet given birth or <24 hours postpartum
• BP >=90 mmHg diastolic or >=140 mmHg systolic on at least 2 occasions
• Proteinuria 1+ (30 mg/dL) or more
• Clinical uncertainty about whether magnesium sulphate would be beneficial

Exclusion Criteria

• Hypersensitivity to magnesium
• Hepatic coma with risk of renal failure
• Myasthenia gravis

Baseline Characteristics

• Demographics: Age ## years

Interventions

• Magnesium sulphate or placebo
• Treatment pack contained 9x 10ml ampoules of 5 g of magnesium sulphate heptahydrate 50% solution or 10 ml ampoules of normal saline
  • Loading dose was 8 mL trial treatment (4 g magnesium sulphate, or placebo) followed by maintanence regimen - IV infusion 1 g/h magnesium sulphate, or placebo or IM 5 g magnesium sulphate or placebo q4h for 24h.

Outcomes

Comparisons are magnesium sulphate vs. placebo.

Primary Outcomes

OUTCOME NAME

##% vs. ##% (HR ##; 95% CI ##-##; P=##)

Funding

• UK Medical Research Council
• UK Department for International Development
• The UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP)