Objective The aim of this study was to assess long-term effects for women following the use of magnesium sulphate for pre-eclampsia.Design Assessment at 2-3 years after delivery for women recruited to the Magpie Trial (recruitment in 1998(recruitment in -2001, which compared magnesium sulphate with placebo for pre-eclampsia.Setting Follow up after discharge from hospital at 125 centres in 19 countries across five continents.Population A total of 7927 women were randomised at the followup centres. Of these women, 2544 were not included for logistic reasons and 601 excluded (109 at a centre where <20% of women were contacted, 466 discharged without a surviving child and 26 opted out). Therefore, 4782 women were selected for follow-up, of whom 3375 (71%) were traced.Methods Questionnaire assessment was administered largely by post or in a dedicated clinic. Interview assessment of selected women was performed.Main outcome measures Death or serious morbidity potentially related to pre-eclampsia at follow up, other morbidity and use of health service resources.Results Median time from delivery to follow up was 26 months (interquartile range 19-36). Fifty-eight of 1650 (3.5%) women allocated magnesium sulphate died or had serious morbidity potentially related to pre-eclampsia compared with 72 of 1725 (4.2%) women allocated placebo (relative risk 0.84, 95% CI 0.60-1.18). ConclusionsThe reduction in the risk of eclampsia following prophylaxis with magnesium sulphate was not associated with an excess of death or disability for the women after 2 years.
Objectives This work aimed to assess the diagnostic validity of two approaches for the screening of gestational diabetes mellitus (GDM) with less discomfort for pregnant women. Methods A prospective diagnostic validation study was conducted with 2007 pregnant women. According to risk factors for GDM, women were classified into high-risk and low-risk groups. The current diagnostic procedure, based on oral glucose overload, was followed; simultaneously HbA1c was tested and an algorithm combining both biomarkers was applied. Results In the low-risk group, the Glucose challenge test (GCT) showed a higher area under the curve (AUC 0.953; 95% CI 0.915–0.992) than the HbA1c test (0.688; 95% CI 0.541–0.834). The best GCT cut-off, 153.5 mg/dL (8.52 mmol/L), showed higher diagnostic validity than that for HbA1c, 28 mmol/mol (4.75%), and that the algorithm using both tests. In the high-risk group, the GCT showed better diagnostic performance than the HbA1c and the algorithm; the optimal GCT cut-offs were higher than those recommended in current protocols. 13th week: GCT AUC 0.882 (95% CI 0.843–0.921), HbA1c AUC 0.624 (95% CI 0.562–0.686), GCT cut-off 140.5 mg/dL (7.8 mmol/L), HbA1c cut-off 33 mmol/mol (5.15%). 24th week: GCT AUC 0.944 (95% CI 0.925–0.962), HbA1c AUC 0.642 (95% CI 0.575–0.709), GCT cut-off, 145.5 mg/dL (8.08 mmol/L), HbA1c cut-off 29 mmol/mol (4.85%). Conclusions The GDM diagnostic approach using as the first step the GCT with higher cut-offs showed the best diagnostic validity. Applying these thresholds, 55.6 and 13.7% of 100 g. Oral glucose overloads would have been avoided in low-risk and high-risk pregnant women.
Resumen Objetivos El objetivo de este trabajo es evaluar la validez diagnóstica de dos métodos de cribado de diabetes mellitus gestacional (DMG). Métodos Se realizó un estudio prospectivo de validación diagnóstica en 2007 embarazadas. Las participantes fueron asignadas al grupo de alto o bajo riesgo, dependiendo de los factores de riesgo que presentaran. Se realizó una prueba de HbA1c simultáneamente al protocolo estándar basado en el test de O’Sullivan (TOS). Posteriormente, se aplicó un algoritmo que combinaba los resultados de ambos biomarcadores. Resultados En el grupo de bajo riesgo, el TOS mostró un área bajo la curva mayor (AUC 0,953; IC95% 0,915–0,992) que la prueba de HbA1c (0,688; IC 95% 0,541–0,834). El mejor punto de corte del TOS, 153,5 mg/dL (8,52 mmol/L), mostró mayor validez diagnóstica que el de la HbA1c, 28 mmol/mol (4,75%) y que el algoritmo basado en ambas pruebas. En el grupo de alto riesgo, el TOS mostró mejor rendimiento diagnóstico que la HbA1c y el algoritmo. Los puntos de corte óptimos para el TOS fueron mayores que los recomendados en los protocolos actuales. Semana 13: TOS AUC 0,882 (IC 95% 0,843–0,921), HbA1c AUC 0,624 (IC 95% 0,562–0,686), punto de corte para el TOS 140,5 mg/dL (7,8 mmol/L), punto de corte para la HbA1c 33 mmol/mol (5,15%). Semana 24: TOS AUC 0,944 (IC 95% 0,925–0,962), HbA1c AUC 0,642 (IC 95% 0,575–0,709), punto de corte para el TOS, 145,5 mg/dL (8,08 mmol/L), punto de corte para la HbA1c 29 mmol/mol (4,85%). Conclusiones El método para el cribado de DMG basado en el test de O’Sullivan con valores límite superiores a los recomendados fue el que mostró mejor validez diagnóstica. Si se hubieran aplicado estos umbrales, se habría evitado la prueba de sobrecarga oral de glucosa con 100 g al 55,6% y al 13,7% de las gestantes de bajo y alto riesgo.
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