The Magpie Trial follow up study: outcome after discharge from hospital for women and children recruited to a trial comparing magnesium sulphate with placebo for pre-eclampsia [ISRCTN86938761]

Abstract

BackgroundThe Magpie Trial compared magnesium sulphate with placebo for women with pre-eclampsia. 10,141 women were recruited, 8804 before delivery. Overall, 9024 children were included in the analysis of outcome at discharge from hospital. Magnesium sulphate more than halved the risk of eclampsia, and probably reduced the risk of maternal death. There did not appear to be any substantive harmful effects on the baby, in the short term. It is now important to assess whether these benefits persist, and to provide adequate reassurance about longer term safety.The main objective of the Magpie Trial Follow Up Study is to assess whether in utero exposure to magnesium sulphate has a clinically important effect on the child's chance of surviving without major neurosensory disability. Other objectives are to assess long term outcome for the mother, and to develop and assess appropriate strategies for following up large numbers of children in perinatal trials.Study designFollow up is only feasible in selected centres. We therefore anticipate contacting 2800–3350 families, for 2435–2915 of whom the woman was randomised before delivery. A further 280–335 children would have been eligible for follow up if they had survived. The total sample size for the children is therefore 3080–3685, 2680–3210 of whom will have been born to women randomised before delivery.Families eligible for the follow up will be contacted, and surviving children screened using the Ages and Stages Questionnaires. Children who screen positive, and a sample of those who screen negative, will whenever possible have a paediatric and neurodevelopmental assessment. When women are contacted to ask how their child is, they will also be asked about their own health. The primary outcome is a composite measure of death or neurosensory disability for the child at 18 months.DiscussionThe Follow Up Study began in 2002, and now involves collaborators in 19 countries. Data collection will close at the end of 2003.

The Magpie Trial: a randomised trial comparing magnesium sulphate with placebo for pre‐eclampsia. Outcome for children at 18 months

“…Everyone involved in tracing and assessment remained blind to the allocated treatment. The protocol for follow-up is available elsewhere 17. Outcome for women18 and narrative accounts of the collaborators19 are published separately.…”

“…An additional section addresses general parental concerns, and it is not scored. We added two questions about use of health service resources 17. Up to 24 months, age is adjusted for gestation at birth.…”

“…We added two questions about use of health service resources. 17 Up to 24 months, age is adjusted for gestation at birth. Each questionnaire is valid for 4 weeks either side of the target age.…”

“…Three questions were selected in each of the gross motor, communication and problem solving domains, together with five general questions. 17 To pass, the child had to have at least one ‘yes’ in each domain.…”

Preeclampsia from a renal point of view: Insides into disease models, biomarkers and therapy

“…Magnesium sulphate more than halves the risk of eclampsia [100] . The MagpieTrial compared magnesium sulphate with placebo for women with preeclampsia and found a preventive effect [101,102] . Therefore, prophylactic treatment with magnesium sulfate is indicated for all patients with severe preeclampsia.…”