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1. The Magpie Trial: a randomised trial comparing magnesium sulphate with placebo for pre-eclampsia. Outcome for women at 2 years

Author

Duley, L, Farrell, B, Armstrong, N, Spark, P, Roberts, B, Smyth, R, Tivnan, M, Laws, A, Corfield, N, Salter, 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, Collins, R, Karaoglou, A, Lilford, R, Moodley, J, Robson, S, Roberts, I, Rubin, P, Thornton, J, Twaddle, S, Villar, J, Walker, I, Watkins, C, Doyle, L, 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, Varela, DM, 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, de Speranza, BO, Peyrano, A, Damiano, M, Saumench, C, Horn, J, Pritchard, M, Smith-Orr, V, Wilson, M, Lawrence, A, Watson, D, Crowther, C, Paynter, J, Mannan, M, Shahidullah, M, Shamsuddin, L, Santos, CB, Freire, S, Melo, E, Cobo, E, Jaramillo, M, Cardozo, C, Fandino, N, Gaitan, H, Montano, L, Lozano, J, Rojas, M, Garcia, AB, Ramirez, AF, Miras, RG, Sampera, S, Farnot, U, Gomez, E, Rojas, G, Valdes, R, El-Kreem, HA, Al-Hussaini, T, Hammad, E, Danso, K, Kwapong, E, Ofosu-Barko, F, Jasper, MP, 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, B, 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, 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, Carstens, M, Kirsten, G, Steyn, W, van Zyl, J, Helwig, A, Jacobson, S-L, Panosche, R, Hammond, E, Masanganise, L, and Colla, MTF-US

Subjects
Pediatrics, medicine.medical_specialty, Randomization, pre-eclampsia, magnesium sulphate, Population, Maternal Medicine, Placebo, law.invention, Longterm follow-up, Magnesium Sulfate, Randomized controlled trial, Interquartile range, law, Pregnancy, Risk Factors, Medicine, Humans, Maternal Health Services, education, Child, education.field_of_study, Eclampsia, business.industry, Pregnancy Outcome, Obstetrics and Gynecology, Patient Acceptance of Health Care, medicine.disease, randomised trial, Clinical trial, Maternal Mortality, Relative risk, Anticonvulsants, Female, business, Follow-Up Studies
Abstract

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 1998-2001, ISRCTN 86938761), 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 follow-up centres. Of these women, 2544 were not included for logistic reasons and 601 excluded (109 at a centre where

Published
2006

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

Author

Duley, L, Farrell, B, Armstrong, N, Spark, P, Roberts, B, Smyth, R, Tivnan, M, Laws, A, Corfield, N, Salter, 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, Farri, M, Kerz, G, Aguirre, J, de Sagastiza, M, Falcone, R, Morales, E, Carroli, G, Krupitzky, S, Lopez, S, Palermo, M, Varela, DM, 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, de Speranza, BO, Peyrano, A, Damiano, M, Saumench, C, Horn, J, Pritchard, M, Smith-Orr, V, Wilson, M, Lawrence, A, Watson, D, Crowther, C, Paynter, J, Mannan, M, Shahidullah, M, Shamsuddin, L, Barros Santos, C, Freire, S, Melo, E, Cobo, E, Jaramillo, M, 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, Valdez, R, El-Kreem, HA, Al-Hussaini, T, Hammad, E, Danso, K, Kwapong, E, Ofosu-Barko, F, Jasper, MP, 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, B, 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, Faiz, NR, Gul, F, Sherin, A, Bangash, K, Mahmud, G, Masud, K, Tasneem, N, Gassama, S, Soyei, A, Agarwal, P, Rajadurai, V, Hani, C, Pirani, N, Delport, S, Macdonald, P, Mokhondo, R, Pattinson, R, Zondo, M, Adhikari, M, Mnguni, N, Carstens, M, Kirsten, G, Steyn, W, van Zyl, J, Helwig, A, Jacobson, S-L, Panosche, R, Hammond, E, Masanganise, L, and Collabor, MTFS

Subjects
Pediatrics, medicine.medical_specialty, pre-eclampsia, magnesium sulphate, Maternal Medicine, Placebo, Preeclampsia, law.invention, Longterm follow-up, Disability Evaluation, Magnesium Sulfate, Randomized controlled trial, law, Pregnancy, medicine, Humans, reproductive and urinary physiology, Cause of death, Eclampsia, business.industry, Pregnancy Outcome, Obstetrics and Gynecology, Infant, medicine.disease, randomised trial, female genital diseases and pregnancy complications, Disabled Children, Clinical trial, In utero, Prenatal Exposure Delayed Effects, Sensation Disorders, Anticonvulsants, Female, Nervous System Diseases, business
Abstract

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

Published
2007

3. Ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a systematic review and individual participant data meta-analysis

Author

Agata Majewska, Jessica A Marathe, Jenny Chambers, Romana Brun-Furrer, Ugo Indraccolo, Yue Cui, Stefan C. Kane, George Attilakos, Maria C. Estiú, L.F. Audris Wong, Andrew Shennan, Rachel M. Tribe, Michael J. Peek, Richard H. Lee, Keren Zloto, Jim G Thornton, Hanns-Ulrich Marschall, Tharni Vasavan, Yoav Yinon, Yannick Bacq, Caroline Ovadia, Berrin Günaydin, Xiaohua Liu, Yayi Hu, Catherine Williamson, Jūratė Kondrackienė, Ayse Gul Kebapcilar, Martijn A. Oudijk, Qianwen Zhang, Kasia Maksym, Victoria Geenes, William M. Hague, Alexander Juusela, Min Ding, Levent Kebapcilar, Valeria Tripodi, Deniz Oztekin, Kajol Patel, Rocio I.R. Macias, Nicholas A. Williamson, Christian Haslinger, Monika Grymowicz, Linoy Batsry, Fergus W. Gardiner, Naciye Turk Ozterlemez, Riza Madazli, Lucy C Chappell, Peter H. Dixon, Paul T. Seed, Anna Locatelli, Kelsey Broom, Maria P.H. Koster, Laura N. Bull, Jenna Sajous, Adam Morton, Francesco Azzaroli, Katherine Kohari, Ovadia C., Sajous J., Seed P.T., Patel K., Williamson N.J., Attilakos G., Azzaroli F., Bacq Y., Batsry L., Broom K., Brun-Furrer R., Bull L., Chambers J., Cui Y., Ding M., Dixon P.H., Estiu M.C., Gardiner F.W., Geenes V., Grymowicz M., Gunaydin B., Hague W.M., Haslinger C., Hu Y., Indraccolo U., Juusela A., Kane S.C., Kebapcilar A., Kebapcilar L., Kohari K., Kondrackiene J., Koster M.P.H., Lee R.H., Liu X., Locatelli A., Macias R.I.R., Madazli R., Majewska A., Maksym K., Marathe J.A., Morton A., Oudijk M.A., Oztekin D., Peek M.J., Shennan A.H., Tribe R.M., Tripodi V., Turk Ozterlemez N., Vasavan T., Wong L.F.A., Yinon Y., Zhang Q., Zloto K., Marschall H.-U., Thornton J., Chappell L.C., Williamson C., Obstetrics and Gynaecology, ARD - Amsterdam Reproduction and Development, Ovadia, C, Sajous, J, Seed, P, Patel, K, Williamson, N, Attilakos, G, Azzaroli, F, Bacq, Y, Batsry, L, Broom, K, Brun-Furrer, R, Bull, L, Chambers, J, Cui, Y, Ding, M, Dixon, P, Estiu, M, Gardiner, F, Geenes, V, Grymowicz, M, Gunaydin, B, Hague, W, Haslinger, C, Hu, Y, Indraccolo, U, Juusela, A, Kane, S, Kebapcilar, A, Kebapcilar, L, Kohari, K, Kondrackiene, J, Koster, M, Lee, R, Liu, X, Locatelli, A, Macias, R, Madazli, R, Majewska, A, Maksym, K, Marathe, J, Morton, A, Oudijk, M, Oztekin, D, Peek, M, Shennan, A, Tribe, R, Tripodi, V, Turk Ozterlemez, N, Vasavan, T, Wong, L, Yinon, Y, Zhang, Q, Zloto, K, Marschall, H, Thornton, J, Chappell, L, Williamson, C, Obstetrics & Gynecology, and Amsterdam Reproduction & Development (AR&D)

Subjects
Cholagogues and Choleretics, medicine.medical_specialty, medicine.drug_class, Cholestasis, Intrahepatic, 03 medical and health sciences, 0302 clinical medicine, Cholestasis, Pregnancy, Internal medicine, Cholestasis of pregnancy, Humans, Medicine, Hepatology, Bile acid, business.industry, Obstetrics, Individual participant data, Gastroenterology, Obstetrics and Gynecology, General Medicine, Odds ratio, medicine.disease, Ursodeoxycholic acid, Pregnancy Complications, 030220 oncology & carcinogenesis, Meta-analysis, Female, 030211 gastroenterology & hepatology, stillbirth, Ursodeoxycholic acid, pregnancy, intrahepatic cholestasis of pregnancy, business, medicine.drug, Cohort study
Abstract

Background: Ursodeoxycholic acid is commonly used to treat intrahepatic cholestasis of pregnancy, yet its largest trial detected minimal benefit for a composite outcome (stillbirth, preterm birth, and neonatal unit admission). We aimed to examine whether ursodeoxycholic acid affects specific adverse perinatal outcomes. Methods: In this systematic review and individual participant data meta-analysis, we searched PubMed, Web of Science, Embase, MEDLINE, CINAHL, Global Health, MIDIRS, and Cochrane without language restrictions for relevant articles published between database inception, and Jan 1, 2020, using search terms referencing intrahepatic cholestasis of pregnancy, ursodeoxycholic acid, and perinatal outcomes. Eligible studies had 30 or more study participants and reported on at least one individual with intrahepatic cholestasis of pregnancy and bile acid concentrations of 40 μmol/L or more. We also included two unpublished cohort studies. Individual participant data were collected from the authors of selected studies. The primary outcome was the prevalence of stillbirth, for which we anticipated there would be insufficient data to achieve statistical power. Therefore, we included a composite of stillbirth and preterm birth as a main secondary outcome. A mixed-effects meta-analysis was done using multi-level modelling and adjusting for bile acid concentration, parity, and multifetal pregnancy. Individual participant data analyses were done for all studies and in different subgroups, which were produced by limiting analyses to randomised controlled trials only, singleton pregnancies only, or two-arm studies only. This study is registered with PROSPERO, CRD42019131495. Findings: The authors of the 85 studies fulfilling our inclusion criteria were contacted. Individual participant data from 6974 women in 34 studies were included in the meta-analysis, of whom 4726 (67·8%) took ursodeoxycholic acid. Stillbirth occurred in 35 (0·7%) of 5097 fetuses among women with intrahepatic cholestasis of pregnancy treated with ursodeoxycholic acid and in 12 (0·6%) of 2038 fetuses among women with intrahepatic cholestasis of pregnancy not treated with ursodeoxycholic acid (adjusted odds ratio [aOR] 1·04, 95% CI 0·35–3·07; p=0·95). Ursodeoxycholic acid treatment also had no effect on the prevalence of stillbirth when considering only randomised controlled trials (aOR 0·29, 95% CI 0·04–2·42; p=0·25). Ursodeoxycholic acid treatment had no effect on the prevalence of the composite outcome in all studies (aOR 1·28, 95% CI 0·86–1·91; p=0·22), but was associated with a reduced composite outcome when considering only randomised controlled trials (0·60, 0·39–0·91; p=0·016). Interpretation: Ursodeoxycholic acid treatment had no significant effect on the prevalence of stillbirth in women with intrahepatic cholestasis of pregnancy, but our analysis was probably limited by the low overall event rate. However, when considering only randomised controlled trials, ursodeoxycholic acid was associated with a reduction in stillbirth in combination with preterm birth, providing evidence for the clinical benefit of antenatal ursodeoxycholic acid treatment. Funding: Tommy's, the Wellcome Trust, ICP Support, and the National Institute for Health Research.

Published
2021

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