L Duley1, A M Gülmezoglu, D J Henderson-Smart. 1. Resource Centre for Randomised Trials, Institute of Health Sciences, Old Road, Headington, Oxford, UK, OX3 7LF. lelia.duley@ndm.ox.ac.uk
Abstract
BACKGROUND: Pre-eclampsia is a relatively common complication of pregnancy. Eclampsia, the occurrence of one or more convulsions (fits) in association with the syndrome of pre-eclampsia, is a rare but serious complication. Anticonvulsants are used in the belief they help prevent eclamptic fits and so improve outcome. OBJECTIVES: The objective was to assess the effects of anticonvulsants for pre-eclampsia on the women and their children. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register (28 November 2002), and the Cochrane Controlled Trials Register (The Cochrane Library, Issue 3, 2002). SELECTION CRITERIA: Randomised trials comparing anticonvulsants with placebo or no anticonvulsants or comparisons of different anticonvulsants in women with pre-eclampsia. DATA COLLECTION AND ANALYSIS: Two reviewers assessed trial quality and extracted data independently. MAIN RESULTS: Six trials (11,444 women) compared magnesium sulphate with placebo or no anticonvulsant. There was more than a halving in the risk of eclampsia associated with magnesium sulphate (relative risk (RR) 0.41, 95% confidence interval (CI) 0.29 to 0.58; number needed to treat (NNT) 100, 95% CI 50 to 100). The risk of dying was non-significantly reduced by 46% for women allocated magnesium sulphate (RR 0.54, 95% CI 0.26 to 1.10). For serious maternal morbidity RR 1.08, 95% CI 0.89 to 1.32. Side effects were more common with magnesium sulphate (24% versus 5%; RR 5.26, 95% CI 4.59 to 6.03; NNT for harm 6, 95% CI 6 to 5). The main side effect was flushing. Risk of placental abruption was reduced for women allocated magnesium sulphate (RR 0.64, 95% CI 0.50 to 0.83; NNT 100, 95% CI 50 to 1000). Women allocated magnesium sulphate had a small increase (5%) in the risk of caesarean section (95% CI 1% to 10%). There was no overall difference in the risk of stillbirth or neonatal death (RR 1.04, 95% CI 0.93 to 1.15). Magnesium sulphate was better than phenytoin for reducing the risk of eclampsia (two trials 2241 women; RR 0.05, 95% CI 0.00 to 0.84), but with an increased risk of caesarean section (RR 1.21, 95% CI 1.05 to 1.41). It was also better than nimodipine (1 trial, 1650 women; RR 0.33, 95% CI 0.14 to 0.77). REVIEWER'S CONCLUSIONS: Magnesium sulphate more than halves the risk of eclampsia, and probably reduces the risk of maternal death. It does not improve outcome for the baby, in the short term. A quarter of women have side effects, particularly flushing.
BACKGROUND: Pre-eclampsia is a relatively common complication of pregnancy. Eclampsia, the occurrence of one or more convulsions (fits) in association with the syndrome of pre-eclampsia, is a rare but serious complication. Anticonvulsants are used in the belief they help prevent eclamptic fits and so improve outcome. OBJECTIVES: The objective was to assess the effects of anticonvulsants for pre-eclampsia on the women and their children. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register (28 November 2002), and the Cochrane Controlled Trials Register (The Cochrane Library, Issue 3, 2002). SELECTION CRITERIA: Randomised trials comparing anticonvulsants with placebo or no anticonvulsants or comparisons of different anticonvulsants in women with pre-eclampsia. DATA COLLECTION AND ANALYSIS: Two reviewers assessed trial quality and extracted data independently. MAIN RESULTS: Six trials (11,444 women) compared magnesium sulphate with placebo or no anticonvulsant. There was more than a halving in the risk of eclampsia associated with magnesium sulphate (relative risk (RR) 0.41, 95% confidence interval (CI) 0.29 to 0.58; number needed to treat (NNT) 100, 95% CI 50 to 100). The risk of dying was non-significantly reduced by 46% for women allocated magnesium sulphate (RR 0.54, 95% CI 0.26 to 1.10). For serious maternal morbidity RR 1.08, 95% CI 0.89 to 1.32. Side effects were more common with magnesium sulphate (24% versus 5%; RR 5.26, 95% CI 4.59 to 6.03; NNT for harm 6, 95% CI 6 to 5). The main side effect was flushing. Risk of placental abruption was reduced for women allocated magnesium sulphate (RR 0.64, 95% CI 0.50 to 0.83; NNT 100, 95% CI 50 to 1000). Women allocated magnesium sulphate had a small increase (5%) in the risk of caesarean section (95% CI 1% to 10%). There was no overall difference in the risk of stillbirth or neonatal death (RR 1.04, 95% CI 0.93 to 1.15). Magnesium sulphate was better than phenytoin for reducing the risk of eclampsia (two trials 2241 women; RR 0.05, 95% CI 0.00 to 0.84), but with an increased risk of caesarean section (RR 1.21, 95% CI 1.05 to 1.41). It was also better than nimodipine (1 trial, 1650 women; RR 0.33, 95% CI 0.14 to 0.77). REVIEWER'S CONCLUSIONS:Magnesium sulphate more than halves the risk of eclampsia, and probably reduces the risk of maternal death. It does not improve outcome for the baby, in the short term. A quarter of women have side effects, particularly flushing.
Authors: Godfrey Woelk; Karen Daniels; Julie Cliff; Simon Lewin; Esperança Sevene; Benedita Fernandes; Alda Mariano; Sheillah Matinhure; Andrew D Oxman; John N Lavis; Cecilia Stålsby Lundborg Journal: Health Res Policy Syst Date: 2009-12-30