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

Duley, L. ; Farrell, B. ; Armstrong, N. ; Spark, P. ; Roberts, B. ; Smyth, R. ; Tivnan, M. ; Laws, A. ; Corfield, N. ; Salte, A. ; Thorn, L. ; Altman, D. ; Yu, L. M. ; Abalos, E. ; Carroli, B. ; Dellepiane, L. ; Duarte, M. ; Fernandez, H. ; Giordano, D. ; Clarke, M. ; Gray, A. ; Hey, E. ; Neilson, J. ; Simon, J. ; Doyle, L. ; Kelly, T. ; Squires, J. ; Collins, R. ; Karaoglou, A. ; Lilford, R. ; Moodley, J. ; Robson, S. ; Roberts, I. ; Rubin, P. ; Thornton J. ; Twaddle, S. ; Villar, J. ; Walker, I. ; Watkins, C. ; Bimbashi, A. ; Demalia, E. ; Gliozheni ,O. ; Shpata, A. ; Karolinski, A. ; Lamas, M. ; Pesaresi, M. ; Wainer, V. ; Barbato, W. ; Paciocco, M. ; Bertin, M. ; Boiza, E. ; Castaldi, J. ; Partida, Y. ; Arias, C. ; Farri, M. ; Kerz, G. ; Aguirre, J. ; De Sagastizabal, M. ; Falcone, R. ; Morales, E. ; Carroli, G. ; Krupitzky, S. ; Lopez, S. ; Palermo, M. ; Montes, Varela D. ; Delprato, H. ; Camusso, H. ; Curioni, M. ; Ludmer, E. ; Brandi, R. ; Martin, R. ; Mesas, W. ; Taralli, R. ; Lezaola, M. ; Morosini, M. ; Andina, E. ; Bernal, L. ; Estiu, M. ; Ulens, E. ; Ortiz De Speranza, B. ; Peyrano, A. ; Damiano, M. ; Saumench, C. ; Horn, J. ; Pritchard, M. ; Smith-Orr, V. ; Wilson, M. ; Lawrence, A. ; Watson, D. ; Crowther, C. ; Paynter, J. ; Ashrafunnessa, ; Mannan, M. ; Shahidullah, M. ; Shamsuddin, L. ; Barros, Santos C. ; Freire, S. ; Melo, E. ; Cobo, E. ; Jaramillo, E. ; Cardozo, C. ; Fandino, N. ; Gaitan, H. ; Montano, L. ; Lozano, J. ; Rojas, M. ; Breto, Garcia A. ; Fuentes, Ramirez A. ; Garcia, Miras R. ; Sampera, S. ; Farnot, U. ; Gomez, E. ; Rojas, G. ; Valdes, R. ; Abd El-Kreem, H. ; Al-Hussaini, T. ; Hammad, E. ; Danso, K. ; Kwapong, E. ; Ofosu-Barko, E. ; Padmini, Jasper M. ; Peedicayil, A. ; Regi, A. ; Sharma, R. ; Chauhan, A. ; Raut, V. ; Udani, R. ; Batra, S. ; Muthal-Rathore, A. ; Ramji, S. ; Zutshi, V. ; Balakrishnan, S. ; Eapen, E. ; Koshy, G. ; Ambardar, N. ; Vadakkepat, P. ; Vaidya, D. ; Lema, V. ; Rijken, Y. ; Tadesse, E. ; Dada, O. ; Sofekun, A. ; Ohiaeri, C. ; Runsewe-Abiodun, T. ; Adewole, I. ; Adeyemo, A. ; Brown, B. ; Oladokun, R. ; Adewale, O. ; Inimgba, N. ; John, C. ; Ogu, R. ; Ekele, B. ; Isah, A. ; Onankpa, B. ; Jamelle, R. ; Junejo, D. ; Ruby, Faiz N. ; Gul, F. ; Sherin, A. ; Bangash, K. ; Mahmud, G. ; Masud, K. ; Tasneem, N. ; Gassama, S. ; Soyei, A. ; Agarwal, P. ; Rajadurai, V. ; Pirani, N. ; Delport, S. ; Macdonald, P. ; Mokhondo, R. ; Pattinson, R. ; Zondo, M. ; Adhikari, M. ; Mnguni, N. ; Moodley, J. ; Carstens, M. ; Kirsten, G. ; Steyn, W. ; Van Zyl, J. ; Helwig, A. ; Jacobson, S. L. ; Panosche, R. ; Hammond, E. ; Masanganise, L. (2007)

Article

Objective: To assess the long-term effects of in utero exposure to magnesium sulphate for children whose mothers had pre-eclampsia. Design: Assessment at 18 months of age for children whose mothers were recruited to the Magpie Trial (recruitment 1998-2001 ISRCTN 86938761), which compared magnesium sulphate with placebo. Setting: Follow-up of children born at 125 centres in 19 countries across five continents. Population: A total of 6922 children were born to women randomised before delivery at follow-up centres. Of these, 2271 were not included for logistic reasons and 168 were excluded (101 at a centre where <20% were contacted, 40 whose death or disability was due to a problem at conception or embryogenesis and 27 whose parent/s opted out). Therefore, 4483 children were included in follow-up, of whom 3283 (73%) were contacted. Methods: Assessment by questionnaire, with interview and neurodevelopmental testing of selected children. Main outcome measures: Death or neurosensory disability at age of 18 months. Results: Of those allocated magnesium sulphate, 245/1635 (15.0%) were dead or had neurosensory disability at 18 months compared with 233/1648 (14.1%) allocated placebo (relative risk [RR] 1.06, 95% CI 0.90-1.25), and of survivors, 19/1409 (1.3%) had neurosensory disability at 18 months compared with 27/1442 (1.9%) (RR 0.72, 95% CI 0.40-1.29). There were no substantial differences in causes of death or in the risk of individual impairments or disabilities. Conclusions: The lower risk of eclampsia following prophylaxis with magnesium sulphate was not associated with a clear difference in the risk of death or disability for children at 18 months. © RCOG 2006 BJOG An International Journal of Obstetrics and Gynaecology.

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