OB-GYN-L Messages for June, 1998: Re: Preeclampsia Lab Package

Re: Preeclampsia Lab Package

From: Peter Wein

p.wein@obsgyn-mercy.unimelb.EDU.AU

Sun Jun 28 00:25:20 1998

>You are quite wrong!
>
>The Lancet paper established that MgSO4 was superior to phenytoin and
>diazepam in secondary prophylaxis of eclampsia. That is they showed
>MgSO4 was the best way to stop a woman who'd fitted from having another
>fit. There are one or two of my colleagues who would even quibble about
>that (my favourite sceptic feels it may be wrong to extrapolate from the
>setting of the study to our own unit).
>
>No study to date has really established that MgSO4 is superior to
>placebo in pre-eclamptic women. Nor has any study established what level
>of pre-eclampsia needs MgSO4. MAGPIE is an RCT which aims to do this. It
>is being run by the same coordinator as the Lancet paper had (Lelia
>Duley).
>>

Malcolm - there are trials which in the setting of women who have not yet fitted show that MgSO4 is clearly effective in prevention of eclampsia - in units which I am sure are not dissimilar to yours - not in South America or India. It is true that it is not clear which specific women will benefit, but the agent is clearly effective.

TI: A case-control evaluation of treatment efficacy: the example of magnesium sulfate prophylaxis against eclampsia in patients with preeclampsia. AU: Abi-Said-D; Annegers-JF; Combs-Cantrell-D; Suki-R; Frankowski-RF; Willmore-LJ AD: University of Texas Houston Health Science Center School of Public Health 77030, USA. SO: J-Clin-Epidemiol. 1997 Apr; 50(4): 419-23 *LHM: Journal is held in the Medical Library from *LHC: v.41- 1988- ISSN: 0895-4356 PY: 1997 LA: ENGLISH CP: ENGLAND AB: Randomized trials are the optimal approach for evaluations of treatment efficacy but may not always be feasible. We study the adequacy of the case-control design in evaluating efficacy in a situation where the investigated therapy, namely the administration of magnesium sulfate for the prevention of eclampsia in patients with preeclampsia, has a suspected strong protective effect. A total of 66 cases of eclampsia were ascertained from among deliveries occurring between 1977 and 1992 at two hospitals in Houston, Texas. Randomly selected preeclamptic controls were matched to cases based on hospital and month of delivery. Magnesium sulfate administration prior to seizure occurrence had a strong protective effect against eclampsia in patients with preeclampsia (OR, 0.02; 95% CI, 0.01-0.05). This protective effect remained when controls were stratified by the degree of severity of preeclampsia (mild-to-moderate OR, 0.03, 95% CI, 0.01-0.09 and severe OR, 0.005; 95% CI, 0.0005-0.04) and when cases were stratified by the timing of the first seizure (antepartum and intrapartum seizures OR, 0.01; 95% CI, 0.003-0.05 and postpartum seizures OR, 0.03; 95% CI, 0.005-0.15). The effect also remained after adjustment for other important predictors in a multivariate logistic regression model (OR, 0.11; 95% CI, 0.03-0.38). The results of this study are in support of a recent randomized trial on the efficacy of magnesium sulfate as a prophylactic agent against eclampsia. Although there are serious potential sources of bias in this study, the magnitude of the protective effect of magnesium sulfate minimizes the likelihood that this effect can be explained by bias. Observational studies could be appropriate complements or alternatives to randomized trials in situations where a strong treatment effect is expected. MESH: Adult-; Bias-Epidemiology; Case-Control-Studies; Disease-Progression; Evaluation-Studies; Logistic-Models; Odds-Ratio; Pregnancy-; Randomized-Controlled-Trials; Risk-Factors MESH: *Eclampsia-prevention-and-control; *Magnesium-Sulfate-therapeutic-use; *Pre-Eclampsia-drug-therapy; *Tocolytic-Agents-therapeutic-use; *Treatment-Outcome

TI: Magnesium sulphate in the treatment of eclampsia and pre-eclampsia: an overview of the evidence from randomised trials [see comments] CM: Comment in: Br J Obstet Gynaecol 1996 Nov;103(11):vii AU: Chien-PF; Khan-KS; Arnott-N AD: Department of Obstetrics And Gynaecology, Ninewells Hospital, Dundee, UK. SO: Br-J-Obstet-Gynaecol. 1996 Nov; 103(11): 1085-91 *LHM: Journal is held in the Medical Library from *LHC: v.82- 1975- ISSN: 0306-5456 PY: 1996 LA: ENGLISH CP: ENGLAND AB: OBJECTIVE: To evaluate the effectiveness of magnesium sulphate in the treatment of eclampsia and pre-eclampsia by a systematic quantitative overview of controlled clinical trials. DESIGN: Online searching of the MEDLINE database between 1966 and 1995, and scanning of the bibliography of known primary studies and review articles on the use of magnesium sulphate in eclampsia and pre-eclampsia. Study-selection, study quality assessment and data extraction were performed independently by two reviewers under masked conditions. Where possible outcome data from trials were pooled and summarised using the Mantel-Haenszel method. PARTICIPANTS: One thousand seven hundred and forty-three women with eclampsia and 2390 with pre-eclampsia included in nine randomised trials that evaluated the effects of magnesium sulphate. MAIN OUTCOME MEASURES: Seizure activity and maternal death. RESULTS: In eclampsia, recurrence of seizures was less common with magnesium sulphate therapy compared with phenytoin (odds ratio [OR] 0.27, 95% CI 0.17-0.45, P = 0.00) and diazepam (OR 0.41, 95% CI 0.30-0.57, P 0.00). As indicated by the point estimate, there was a trend towards a reduction in maternal mortality with magnesium sulphate in eclampsia (OR 0.51, 95% CI 0.24-1.07, P = 0.10 versus phenytoin; OR 0.78, 95% CI 0.41-1.45, P = 0.52 versus diazepam). When used for seizure prophylaxis in pre-eclampsia, magnesium sulphate was found to be more effective than phenytoin (OR 0.15, 95% CI 0.03-0.72, P = 0.01). CONCLUSION: Magnesium sulphate is a superior drug in preventing the recurrence of seizures in eclampsia and in seizure prophylaxis in pre-eclampsia. MESH: Double-Blind-Method; Maternal-Mortality; Observer-Variation; Pre-Eclampsia-drug-therapy; Pregnancy-; Randomized-Controlled-Trials-standards; Recurrence-; Treatment-Outcome MESH: *Anticonvulsants-therapeutic-use; *Eclampsia-drug-therapy; *Magnesium-Sulfate-therapeutic-use; *Randomized-Controlled-Trials; *Tocolytic-Agents-therapeutic-use

TI: A comparison of magnesium sulfate with phenytoin for the prevention of eclampsia [see comments] CM: Comment in: N Engl J Med 1995 Jul 27;333(4):250-1 AU: Lucas-MJ; Leveno-KJ; Cunningham-FG AD: Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas 75235-9032, USA. SO: N-Engl-J-Med. 1995 Jul 27; 333(4): 201-5 *LHM: Journal is held in the Medical Library from *LHC: v.198- 1928- ISSN: 0028-4793 PY: 1995 LA: ENGLISH CP: UNITED-STATES AB: BACKGROUND. Magnesium sulfate is used widely to prevent eclamptic seizures in pregnant women with hypertension, but few studies have compared the efficacy of magnesium sulfate with that of other drugs. Anticonvulsant prophylaxis with phenytoin for eclampsia has been recommended, but there are virtually no data to support its efficacy. Our objective was to compare magnesium sulfate with phenytoin in preventing seizures in hypertensive women during labor. METHODS. We randomly assigned women with hypertension who were admitted for delivery to receive either magnesium sulfate or phenytoin. The magnesium sulfate regimen consisted of a 10-g intramuscular loading dose followed by a maintenance dose of 5 g given intramuscularly every four hours. For women with severe preeclampsia, an additional 4-g loading dose was given intravenously. The phenytoin regimen included a 1000-mg loading dose infused over a period of 1 hour, followed by a 500-mg oral dose 10 hours later. With either regimen, anticonvulsant therapy was continued for 24 hours post partum. RESULTS. Ten of 1089 women randomly assigned to the phenytoin regimen had eclamptic convulsions, as compared with none of 1049 women randomly assigned to magnesium sulfate (P = 0.004). There were no significant differences in any risk factors for eclampsia between the two study groups. Maternal and infant outcomes were also similar in the two study groups. CONCLUSIONS. Magnesium sulfate is superior to phenytoin for the prevention of eclampsia in hypertensive pregnant women. These results validate the long-practiced use of magnesium sulfate in the prevention of eclampsia. MESH: Adolescence-; Adult-; Analysis-of-Variance; Eclampsia-blood; Eclampsia-drug-therapy; Hypertension-drug-therapy; Infant,-Newborn; Phenytoin-blood; Pre-Eclampsia-drug-therapy; Pregnancy-; Pregnancy-Complications,-Cardiovascular-drug-therapy; Pregnancy-Outcome; Regression-Analysis; Treatment-Outcome MESH: *Eclampsia-prevention-and-control; *Magnesium-Sulfate-therapeutic-use; *Phenytoin-therapeutic-use

-- Peter Wein Senior Lecturer Department of Obstetrics and Gynaecology University of Melbourne, Mercy Hospital for Women Clarendon Street, East Melbourne 3002 Australia Tel: +61 3 9270 2556 Fax: +61 3 9417 5406 Mobile: 0414 691690

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