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1. Evaluating Progestogens for Preventing Preterm Birth International Collaborative (EPPPIC): Meta-analysis of Individual Participant Data From Randomised Controlled Trials

Author

Mol, B. W., Wood, S., Rode, L., Tabor, A., Aboulghar, M. M., Porcher, R., Senat, M.-V., Bagga, R., Rajaram, S., Azargoon, A., Bahrami, E., Nassar, A., Schuit, E., van Os, M. A., Crowther, C. A., Alfirevic, Z., Beresford, L., Dietz, K. C., Duley, L., Hodkinson, A., Llewellyn, A., Norman, J. E., Norrie, J., Sharif, S., Simmonds, M., Stewart, L. A., Walker, R. A. E., Walley, T., Wright, K., Blackwell, S. C., Caritis, S. N., Combs, C. A., Croswell, J. M., Das, A. F., Dickersin, K., Elimian, A., Grobman, W. A., Maurel, K. A., McKenna, D. S., Moley, K., Mueller, J., OʼBrien, J. M., Rouse, D. J., Sakala, C., Simpson, J. L., Smith, K., Thom, E. A., and Whitlock, E. P.

Published
2021
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2. External validation of prognostic models to predict stillbirth using International Prediction of Pregnancy Complications (IPPIC) Network database: individual participant data meta-analysis

Author

Allotey, J, Whittle, R, Snell, K, Smuk, M, Townsend, R, von Dadelszen, P, Heazell, A, Magee, L, Smith, G, Sandall, J, Thilaganathan, B, Zamora, J, Riley, R, Khalil, A, Thangaratinam, S, Coomarasamy, A, Kwong, A, Savitri, A, Salvesen, K, Bhattacharya, S, Uiterwaal, C, Staff, A, Andersen, L, Olive, E, Redman, C, Sletner, L, Daskalakis, G, Macleod, M, Abdollahain, M, Ramirez, J, Masse, J, Audibert, F, Magnus, P, Jenum, A, Baschat, A, Ohkuchi, A, Mcauliffe, F, West, J, Askie, L, Mone, F, Farrar, D, Zimmerman, P, Smits, L, Riddell, C, Kingdom, J, van de Post, J, Illanes, S, Holzman, C, van Kuijk, S, Carbillon, L, Villa, P, Eskild, A, Chappell, L, Prefumo, F, Velauthar, L, Seed, P, van Oostwaard, M, Verlohren, S, Poston, L, Ferrazzi, E, Vinter, C, Nagata, C, Brown, M, Vollebregt, K, Takeda, S, Langenveld, J, Widmer, M, Saito, S, Haavaldsen, C, Carroli, G, Olsen, J, Wolf, H, Zavaleta, N, Eisensee, I, Vergani, P, Lumbiganon, P, Makrides, M, Facchinetti, F, Sequeira, E, Gibson, R, Ferrazzani, S, Frusca, T, Norman, J, Figueiro, E, Lapaire, O, Laivuori, H, Lykke, J, Conde-Agudelo, A, Galindo, A, Mbah, A, Betran, A, Herraiz, I, Trogstad, L, Steegers, E, Salim, R, Huang, T, Adank, A, Zhang, J, Meschino, W, Browne, J, Allen, R, Costa, F, Klipstein-Grobusch Browne, K, Crowther, C, Jorgensen, J, Forest, J, Rumbold, A, Mol, B, Giguere, Y, Kenny, L, Ganzevoort, W, Odibo, A, Myers, J, Yeo, S, Goffinet, F, Mccowan, L, Pajkrt, E, Teede, H, Haddad, B, Dekker, G, Kleinrouweler, E, Lecarpentier, E, Roberts, C, Groen, H, Skrastad, R, Heinonen, S, Eero, K, Anggraini, D, Souka, A, Cecatti, J, Monterio, I, Pillalis, A, Souza, R, Hawkins, L, Gabbay-Benziv, R, Crovetto, F, Figuera, F, Jorgensen, L, Dodds, J, Patel, M, Aviram, A, Papageorghiou, A, Khan, K, Allotey J., Whittle R., Snell K. I. E., Smuk M., Townsend R., von Dadelszen P., Heazell A. E. P., Magee L., Smith G. C. S., Sandall J., Thilaganathan B., Zamora J., Riley R. D., Khalil A., Thangaratinam S., Coomarasamy A., Kwong A., Savitri A. I., Salvesen K. A., Bhattacharya S., Uiterwaal C. S. P. M., Staff A. C., Andersen L. B., Olive E. L., Redman C., Sletner L., Daskalakis G., Macleod M., Abdollahain M., Ramirez J. A., Masse J., Audibert F., Magnus P. M., Jenum A. K., Baschat A., Ohkuchi A., McAuliffe F. M., West J., Askie L. M., Mone F., Farrar D., Zimmerman P. A., Smits L. J. M., Riddell C., Kingdom J. C., van de Post J., Illanes S. E., Holzman C., van Kuijk S. M. J., Carbillon L., Villa P. M., Eskild A., Chappell L., Prefumo F., Velauthar L., Seed P., van Oostwaard M., Verlohren S., Poston L., Ferrazzi E., Vinter C. A., Nagata C., Brown M., Vollebregt K. C., Takeda S., Langenveld J., Widmer M., Saito S., Haavaldsen C., Carroli G., Olsen J., Wolf H., Zavaleta N., Eisensee I., Vergani P., Lumbiganon P., Makrides M., Facchinetti F., Sequeira E., Gibson R., Ferrazzani S., Frusca T., Norman J. E., Figueiro E. A., Lapaire O., Laivuori H., Lykke J. A., Conde-Agudelo A., Galindo A., Mbah A., Betran A. P., Herraiz I., Trogstad L., Smith G. G. S., Steegers E. A. P., Salim R., Huang T., Adank A., Zhang J., Meschino W. S., Browne J. L., Allen R. E., Costa F. D. S., Klipstein-Grobusch Browne K., Crowther C. A., Jorgensen J. S., Forest J. -C., Rumbold A. R., Mol B. W., Giguere Y., Kenny L. C., Ganzevoort W., Odibo A. O., Myers J., Yeo S. A., Goffinet F., McCowan L., Pajkrt E., Teede H. J., Haddad B. G., Dekker G., Kleinrouweler E. C., LeCarpentier E., Roberts C. T., Groen H., Skrastad R. B., Heinonen S., Eero K., Anggraini D., Souka A., Cecatti J. G., Monterio I., Pillalis A., Souza R., Hawkins L. A., Gabbay-Benziv R., Crovetto F., Figuera F., Jorgensen L., Dodds J., Patel M., Aviram A., Papageorghiou A., Khan K., Allotey, J, Whittle, R, Snell, K, Smuk, M, Townsend, R, von Dadelszen, P, Heazell, A, Magee, L, Smith, G, Sandall, J, Thilaganathan, B, Zamora, J, Riley, R, Khalil, A, Thangaratinam, S, Coomarasamy, A, Kwong, A, Savitri, A, Salvesen, K, Bhattacharya, S, Uiterwaal, C, Staff, A, Andersen, L, Olive, E, Redman, C, Sletner, L, Daskalakis, G, Macleod, M, Abdollahain, M, Ramirez, J, Masse, J, Audibert, F, Magnus, P, Jenum, A, Baschat, A, Ohkuchi, A, Mcauliffe, F, West, J, Askie, L, Mone, F, Farrar, D, Zimmerman, P, Smits, L, Riddell, C, Kingdom, J, van de Post, J, Illanes, S, Holzman, C, van Kuijk, S, Carbillon, L, Villa, P, Eskild, A, Chappell, L, Prefumo, F, Velauthar, L, Seed, P, van Oostwaard, M, Verlohren, S, Poston, L, Ferrazzi, E, Vinter, C, Nagata, C, Brown, M, Vollebregt, K, Takeda, S, Langenveld, J, Widmer, M, Saito, S, Haavaldsen, C, Carroli, G, Olsen, J, Wolf, H, Zavaleta, N, Eisensee, I, Vergani, P, Lumbiganon, P, Makrides, M, Facchinetti, F, Sequeira, E, Gibson, R, Ferrazzani, S, Frusca, T, Norman, J, Figueiro, E, Lapaire, O, Laivuori, H, Lykke, J, Conde-Agudelo, A, Galindo, A, Mbah, A, Betran, A, Herraiz, I, Trogstad, L, Steegers, E, Salim, R, Huang, T, Adank, A, Zhang, J, Meschino, W, Browne, J, Allen, R, Costa, F, Klipstein-Grobusch Browne, K, Crowther, C, Jorgensen, J, Forest, J, Rumbold, A, Mol, B, Giguere, Y, Kenny, L, Ganzevoort, W, Odibo, A, Myers, J, Yeo, S, Goffinet, F, Mccowan, L, Pajkrt, E, Teede, H, Haddad, B, Dekker, G, Kleinrouweler, E, Lecarpentier, E, Roberts, C, Groen, H, Skrastad, R, Heinonen, S, Eero, K, Anggraini, D, Souka, A, Cecatti, J, Monterio, I, Pillalis, A, Souza, R, Hawkins, L, Gabbay-Benziv, R, Crovetto, F, Figuera, F, Jorgensen, L, Dodds, J, Patel, M, Aviram, A, Papageorghiou, A, Khan, K, Allotey J., Whittle R., Snell K. I. E., Smuk M., Townsend R., von Dadelszen P., Heazell A. E. P., Magee L., Smith G. C. S., Sandall J., Thilaganathan B., Zamora J., Riley R. D., Khalil A., Thangaratinam S., Coomarasamy A., Kwong A., Savitri A. I., Salvesen K. A., Bhattacharya S., Uiterwaal C. S. P. M., Staff A. C., Andersen L. B., Olive E. L., Redman C., Sletner L., Daskalakis G., Macleod M., Abdollahain M., Ramirez J. A., Masse J., Audibert F., Magnus P. M., Jenum A. K., Baschat A., Ohkuchi A., McAuliffe F. M., West J., Askie L. M., Mone F., Farrar D., Zimmerman P. A., Smits L. J. M., Riddell C., Kingdom J. C., van de Post J., Illanes S. E., Holzman C., van Kuijk S. M. J., Carbillon L., Villa P. M., Eskild A., Chappell L., Prefumo F., Velauthar L., Seed P., van Oostwaard M., Verlohren S., Poston L., Ferrazzi E., Vinter C. A., Nagata C., Brown M., Vollebregt K. C., Takeda S., Langenveld J., Widmer M., Saito S., Haavaldsen C., Carroli G., Olsen J., Wolf H., Zavaleta N., Eisensee I., Vergani P., Lumbiganon P., Makrides M., Facchinetti F., Sequeira E., Gibson R., Ferrazzani S., Frusca T., Norman J. E., Figueiro E. A., Lapaire O., Laivuori H., Lykke J. A., Conde-Agudelo A., Galindo A., Mbah A., Betran A. P., Herraiz I., Trogstad L., Smith G. G. S., Steegers E. A. P., Salim R., Huang T., Adank A., Zhang J., Meschino W. S., Browne J. L., Allen R. E., Costa F. D. S., Klipstein-Grobusch Browne K., Crowther C. A., Jorgensen J. S., Forest J. -C., Rumbold A. R., Mol B. W., Giguere Y., Kenny L. C., Ganzevoort W., Odibo A. O., Myers J., Yeo S. A., Goffinet F., McCowan L., Pajkrt E., Teede H. J., Haddad B. G., Dekker G., Kleinrouweler E. C., LeCarpentier E., Roberts C. T., Groen H., Skrastad R. B., Heinonen S., Eero K., Anggraini D., Souka A., Cecatti J. G., Monterio I., Pillalis A., Souza R., Hawkins L. A., Gabbay-Benziv R., Crovetto F., Figuera F., Jorgensen L., Dodds J., Patel M., Aviram A., Papageorghiou A., and Khan K.

Abstract

Objective: Stillbirth is a potentially preventable complication of pregnancy. Identifying women at high risk of stillbirth can guide decisions on the need for closer surveillance and timing of delivery in order to prevent fetal death. Prognostic models have been developed to predict the risk of stillbirth, but none has yet been validated externally. In this study, we externally validated published prediction models for stillbirth using individual participant data (IPD) meta-analysis to assess their predictive performance. Methods: MEDLINE, EMBASE, DH-DATA and AMED databases were searched from inception to December 2020 to identify studies reporting stillbirth prediction models. Studies that developed or updated prediction models for stillbirth for use at any time during pregnancy were included. IPD from cohorts within the International Prediction of Pregnancy Complications (IPPIC) Network were used to validate externally the identified prediction models whose individual variables were available in the IPD. The risk of bias of the models and cohorts was assessed using the Prediction study Risk Of Bias ASsessment Tool (PROBAST). The discriminative performance of the models was evaluated using the C-statistic, and calibration was assessed using calibration plots, calibration slope and calibration-in-the-large. Performance measures were estimated separately in each cohort, as well as summarized across cohorts using random-effects meta-analysis. Clinical utility was assessed using net benefit. Results: Seventeen studies reporting the development of 40 prognostic models for stillbirth were identified. None of the models had been previously validated externally, and the full model equation was reported for only one-fifth (20%, 8/40) of the models. External validation was possible for three of these models, using IPD from 19 cohorts (491 201 pregnant women) within the IPPIC Network database. Based on evaluation of the model development studies, all three models had an overa

Published
2022

4. External validation of prognostic models to predict stillbirth using International Prediction of Pregnancy Complications (IPPIC) Network database: individual participant data meta-analysis

Author

Allotey, J., Whittle, R., Snell, K. I. E., Smuk, M., Townsend, R., von Dadelszen, P., Heazell, A. E. P., Magee, L., Smith, G. C. S., Sandall, J., Thilaganathan, B., Zamora, J., Riley, R. D., Khalil, A., Thangaratinam, S., Coomarasamy, A., Kwong, A., Savitri, A. I., Salvesen, K. A., Bhattacharya, S., Uiterwaal, C. S. P. M., Staff, A. C., Andersen, L. B., Olive, E. L., Redman, C., Sletner, L., Daskalakis, G., Macleod, M., Abdollahain, M., Ramirez, J. A., Masse, J., Audibert, F., Magnus, P. M., Jenum, A. K., Baschat, A., Ohkuchi, A., Mcauliffe, F. M., West, J., Askie, L. M., Mone, F., Farrar, D., Zimmerman, P. A., Smits, L. J. M., Riddell, C., Kingdom, J. C., van de Post, J., Illanes, S. E., Holzman, C., van Kuijk, S. M. J., Carbillon, L., Villa, P. M., Eskild, A., Chappell, L., Prefumo, F., Velauthar, L., Seed, P., van Oostwaard, M., Verlohren, S., Poston, L., Ferrazzi, E., Vinter, C. A., Nagata, C., Brown, M., Vollebregt, K. C., Takeda, S., Langenveld, J., Widmer, M., Saito, S., Haavaldsen, C., Carroli, G., Olsen, J., Wolf, H., Zavaleta, N., Eisensee, I., Vergani, P., Lumbiganon, P., Makrides, M., Facchinetti, F., Sequeira, E., Gibson, R., Ferrazzani, S., Frusca, T., Norman, J. E., Figueiro, E. A., Lapaire, O., Laivuori, H., Lykke, J. A., Conde-Agudelo, A., Galindo, A., Mbah, A., Betran, A. P., Herraiz, I., Trogstad, L., Smith, G. G. S., Steegers, E. A. P., Salim, R., Huang, T., Adank, A., Zhang, J., Meschino, W. S., Browne, J. L., Allen, R. E., Costa, F. D. S., Klipstein-Grobusch Browne, K., Crowther, C. A., Jorgensen, J. S., Forest, J. -C., Rumbold, A. R., Mol, B. W., Giguere, Y., Kenny, L. C., Ganzevoort, W., Odibo, A. O., Myers, J., Yeo, S. A., Goffinet, F., Mccowan, L., Pajkrt, E., Teede, H. J., Haddad, B. G., Dekker, G., Kleinrouweler, E. C., Lecarpentier, E., Roberts, C. T., Groen, H., Skrastad, R. B., Heinonen, S., Eero, K., Anggraini, D., Souka, A., Cecatti, J. G., Monterio, I., Pillalis, A., Souza, R., Hawkins, L. A., Gabbay-Benziv, R., Crovetto, F., Figuera, F., Jorgensen, L., Dodds, J., Patel, M., Aviram, A., Papageorghiou, A., Khan, K., Clinicum, HUS Gynecology and Obstetrics, Department of Obstetrics and Gynecology, HUS Children and Adolescents, Lastentautien yksikkö, Children's Hospital, Allotey, J, Whittle, R, Snell, K, Smuk, M, Townsend, R, von Dadelszen, P, Heazell, A, Magee, L, Smith, G, Sandall, J, Thilaganathan, B, Zamora, J, Riley, R, Khalil, A, Thangaratinam, S, Coomarasamy, A, Kwong, A, Savitri, A, Salvesen, K, Bhattacharya, S, Uiterwaal, C, Staff, A, Andersen, L, Olive, E, Redman, C, Sletner, L, Daskalakis, G, Macleod, M, Abdollahain, M, Ramirez, J, Masse, J, Audibert, F, Magnus, P, Jenum, A, Baschat, A, Ohkuchi, A, Mcauliffe, F, West, J, Askie, L, Mone, F, Farrar, D, Zimmerman, P, Smits, L, Riddell, C, Kingdom, J, van de Post, J, Illanes, S, Holzman, C, van Kuijk, S, Carbillon, L, Villa, P, Eskild, A, Chappell, L, Prefumo, F, Velauthar, L, Seed, P, van Oostwaard, M, Verlohren, S, Poston, L, Ferrazzi, E, Vinter, C, Nagata, C, Brown, M, Vollebregt, K, Takeda, S, Langenveld, J, Widmer, M, Saito, S, Haavaldsen, C, Carroli, G, Olsen, J, Wolf, H, Zavaleta, N, Eisensee, I, Vergani, P, Lumbiganon, P, Makrides, M, Facchinetti, F, Sequeira, E, Gibson, R, Ferrazzani, S, Frusca, T, Norman, J, Figueiro, E, Lapaire, O, Laivuori, H, Lykke, J, Conde-Agudelo, A, Galindo, A, Mbah, A, Betran, A, Herraiz, I, Trogstad, L, Steegers, E, Salim, R, Huang, T, Adank, A, Zhang, J, Meschino, W, Browne, J, Allen, R, Costa, F, Klipstein-Grobusch Browne, K, Crowther, C, Jorgensen, J, Forest, J, Rumbold, A, Mol, B, Giguere, Y, Kenny, L, Ganzevoort, W, Odibo, A, Myers, J, Yeo, S, Goffinet, F, Mccowan, L, Pajkrt, E, Teede, H, Haddad, B, Dekker, G, Kleinrouweler, E, Lecarpentier, E, Roberts, C, Groen, H, Skrastad, R, Heinonen, S, Eero, K, Anggraini, D, Souka, A, Cecatti, J, Monterio, I, Pillalis, A, Souza, R, Hawkins, L, Gabbay-Benziv, R, Crovetto, F, Figuera, F, Jorgensen, L, Dodds, J, Patel, M, Aviram, A, Papageorghiou, A, Khan, K, Tampere University, Obstetrics and Gynaecology, APH - Quality of Care, Amsterdam Reproduction & Development (AR&D), APH - Personalized Medicine, APH - Digital Health, and Obstetrics and gynaecology

Subjects
Calibration (statistics), Perinatal Death, Overfitting, Cohort Studies, Fetal Development, 0302 clinical medicine, Discriminative model, 3123 Gynaecology and paediatrics, Models, Pregnancy, GROWTH RESTRICTION, Statistics, Medicine, Prenatal, 030212 general & internal medicine, Ultrasonography, RISK, 030219 obstetrics & reproductive medicine, PRETERM, Radiological and Ultrasound Technology, LOW-DOSE ASPIRIN, DIAGNOSIS TRIPOD, Obstetrics and Gynecology, General Medicine, Statistical, Stillbirth, Prognosis, Pregnancy Complication, external validation, individual participant data, intrauterine death, prediction model, stillbirth, Female, Humans, Infant, Newborn, Models, Statistical, Pregnancy Complications, Regression Analysis, Risk Assessment, Ultrasonography, Prenatal, 3. Good health, PREECLAMPSIA, Meta-analysis, Human, Cohort study, Prognosi, MEDLINE, Regression Analysi, WEEKS GESTATION, 03 medical and health sciences, VELOCIMETRY, Radiology, Nuclear Medicine and imaging, RECURRENCE, business.industry, Infant, Newborn, R1, HYPERTENSIVE DISORDERS, Reproductive Medicine, Sample size determination, Cohort Studie, RG, business, RA, Predictive modelling
Abstract

Objective Stillbirth is a potentially preventable complication of pregnancy. Identifying women at high risk of stillbirth can guide decisions on the need for closer surveillance and timing of delivery in order to prevent fetal death. Prognostic models have been developed to predict the risk of stillbirth, but none has yet been validated externally. In this study, we externally validated published prediction models for stillbirth using individual participant data (IPD) meta-analysis to assess their predictive performance. Methods MEDLINE, EMBASE, DH-DATA and AMED databases were searched from inception to December 2020 to identify studies reporting stillbirth prediction models. Studies that developed or updated prediction models for stillbirth for use at any time during pregnancy were included. IPD from cohorts within the International Prediction of Pregnancy Complications (IPPIC) Network were used to validate externally the identified prediction models whose individual variables were available in the IPD. The risk of bias of the models and cohorts was assessed using the Prediction study Risk Of Bias ASsessment Tool (PROBAST). The discriminative performance of the models was evaluated using the C-statistic, and calibration was assessed using calibration plots, calibration slope and calibration-in-the-large. Performance measures were estimated separately in each cohort, as well as summarized across cohorts using random-effects meta-analysis. Clinical utility was assessed using net benefit. Results Seventeen studies reporting the development of 40 prognostic models for stillbirth were identified. None of the models had been previously validated externally, and the full model equation was reported for only one-fifth (20%, 8/40) of the models. External validation was possible for three of these models, using IPD from 19 cohorts (491 201 pregnant women) within the IPPIC Network database. Based on evaluation of the model development studies, all three models had an overall high risk of bias, according to PROBAST. In the IPD meta-analysis, the models had summary C-statistics ranging from 0.53 to 0.65 and summary calibration slopes ranging from 0.40 to 0.88, with risk predictions that were generally too extreme compared with the observed risks. The models had little to no clinical utility, as assessed by net benefit. However, there remained uncertainty in the performance of some models due to small available sample sizes. Conclusions The three validated stillbirth prediction models showed generally poor and uncertain predictive performance in new data, with limited evidence to support their clinical application. The findings suggest methodological shortcomings in their development, including overfitting. Further research is needed to further validate these and other models, identify stronger prognostic factors and develop more robust prediction models. (c) 2021 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Published
2022

5. My Baby's Movements: A Stepped-Wedge Cluster-Randomised Controlled Trial of a Fetal Movement Awareness Intervention to Reduce Stillbirths

Author

Flenady, V, Gardener, G, Ellwood, D, Coory, M, Weller, M, Warrilow, KA, Middleton, PF, Wojcieszek, AM, Groom, KM, Boyle, FM, East, C, Lawford, H, Callander, E, Said, JM, Walker, SP, Mahomed, K, Andrews, C, Gordon, A, Norman, JE, and Crowther, C

Subjects
Adult, Pregnancy Trimester, Third, Australia, Obstetrics and Gynecology, Prenatal Care, General Medicine, Patient Acceptance of Health Care, Stillbirth, Young Adult, Pregnancy, Humans, 1114 Paediatrics and Reproductive Medicine, Female, Pregnant Women, Obstetrics & Reproductive Medicine, Fetal Movement, 11 Medical and Health Sciences, New Zealand
Abstract

OBJECTIVE: The My Baby's Movements (MBM) trial aimed to evaluate the impact on stillbirth rates of a multifaceted awareness package (the MBM intervention). DESIGN: Stepped-wedge cluster-randomised controlled trial. SETTING: Twenty-seven maternity hospitals in Australia and New Zealand. POPULATION: Women with a singleton pregnancy without major fetal anomaly at ≥28 weeks of gestation from August 2016 to May 2019. METHODS: The MBM intervention was implemented at randomly assigned time points, with the sequential introduction of eight groups of between three and five hospitals at 4-monthly intervals. Using generalised linear mixed models, the stillbirth rate was compared in the control and the intervention periods, adjusting for calendar time, study population characteristics and hospital effects. MAIN OUTCOME MEASURES: Stillbirth at ≥28 weeks of gestation. RESULTS: There were 304 850 births with 290 105 births meeting the inclusion criteria: 150 053 in the control and 140 052 in the intervention periods. The stillbirth rate was lower (although not statistically significantly so) during the intervention compared with the control period (2.2/1000 versus 2.4/1000 births; aOR 1.18, 95% CI 0.93-1.50; P = 0.18). The decrease in stillbirth rate was greater across calendar time: 2.7/1000 in the first versus 2.0/1000 in the last 18 months. No increase in secondary outcomes, including obstetric intervention or adverse neonatal outcome, was evident. CONCLUSIONS: The MBM intervention did not reduce stillbirths beyond the downward trend over time. As a result of low uptake, the role of the intervention remains unclear, although the downward trend across time suggests some benefit in lowering the stillbirth rate. In this study setting, an awareness of the importance of fetal movements may have reached pregnant women and clinicians prior to the implementation of the intervention. TWEETABLE ABSTRACT: The My Baby's Movements intervention to raise awareness of decreased fetal movement did not significantly reduce stillbirth rates.

Published
2022

6. Antenatal magnesium sulphate for preventing cerebral palsy: An economic evaluation of the impact of a quality improvement program.

Author

Keir, A, Rumbold, A, Shepherd, E, Mcintyre, S, Groves, C, Cavallaro, A, Crowther, C, Callander, E, Keir, A, Rumbold, A, Shepherd, E, Mcintyre, S, Groves, C, Cavallaro, A, Crowther, C, and Callander, E

Abstract

Previous work demonstrated that implementing a quality improvement (QI) program improves the uptake of guideline-recommended antenatal magnesium sulphate, a critical intervention known to reduce cerebral palsy risk. Here we estimate potential cost savings attributable to the improved uptake. By expanding coverage from 63 to 83% of eligible women, we estimated that five children potentially would not have received a diagnosis of cerebral palsy, a potential cost saving of $AU4.8 million in lifetime healthcare costs. Our findings strengthen the case for embedding QI approaches in perinatal care to reduce the incidence of cerebral palsy.

Published
2022

7. Antenatal magnesium sulfate to prevent cerebral palsy.

Author

Keir, AK, Shepherd, E, McIntyre, S, Rumbold, A, Groves, C, Crowther, C, Callander, EJ, Keir, AK, Shepherd, E, McIntyre, S, Rumbold, A, Groves, C, Crowther, C, and Callander, EJ

Abstract

Magnesium sulfate given to women before birth at <30 weeks' gestation reduces the risk of cerebral palsy in their children. Our study aimed to assess the impact of a local quality improvement programme, primarily using plan-do-study-act cycles, to increase the use of antenatal magnesium sulfate. After implementing our quality improvement programme, an average of 86% of babies delivered at <30 weeks' gestation were exposed to antenatal magnesium sulfate compared with a historical baseline rate of 63%. Our study strengthens the case for embedding quality improvement programmes in maternal perinatal care to reduce the impact of cerebral palsy on families and society.

Published
2022

8. My Baby's Movements: A Stepped-Wedge Cluster-Randomised Controlled Trial of a Fetal Movement Awareness Intervention to Reduce Stillbirths

Author

Flenady, V., primary, Gardener, G., additional, Ellwood, D., additional, Coory, M., additional, Weller, M., additional, Warrilow, K. A., additional, Middleton, P. F., additional, Wojcieszek, A. M., additional, Groom, K. M., additional, Boyle, F.M., additional, East, C., additional, Lawford, H. L. S., additional, Callander, E., additional, Said, J. M., additional, Walker, S. P., additional, Mahomed, K., additional, Andrews, C., additional, Gordon, A., additional, Norman, J. E., additional, and Crowther, C., additional

Published
2022
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9. Antenatal magnesium sulphate for preventing cerebral palsy: An economic evaluation of the impact of a quality improvement program

Author

Keir, A, Rumbold, A, Shepherd, E, Mcintyre, S, Groves, C, Cavallaro, A, Crowther, C, and Callander, E

Subjects
Magnesium Sulfate, Neuroprotective Agents, Pregnancy, Cerebral Palsy, Cost-Benefit Analysis, Humans, Premature Birth, Female, 1114 Paediatrics and Reproductive Medicine, 1117 Public Health and Health Services, Obstetrics & Reproductive Medicine, Child, Quality Improvement
Abstract

Previous work demonstrated that implementing a quality improvement (QI) program improves the uptake of guideline-recommended antenatal magnesium sulphate, a critical intervention known to reduce cerebral palsy risk. Here we estimate potential cost savings attributable to the improved uptake. By expanding coverage from 63 to 83% of eligible women, we estimated that five children potentially would not have received a diagnosis of cerebral palsy, a potential cost saving of $AU4.8 million in lifetime healthcare costs. Our findings strengthen the case for embedding QI approaches in perinatal care to reduce the incidence of cerebral palsy.

Published
2021

10. The effect of antenatal lifestyle advice for women who are overweight or obese on secondary measures of neonatal body composition: the LIMIT randomised trial

Author

Dodd, J M, Deussen, A R, Mohamad, I, Rifas-Shiman, S L, Yelland, L N, Louise, J, McPhee, A J, Grivell, R M, Owens, J A, Gillman, M W, Robinson, J S, Turnbull, D, Crowther, C, Wittert, G, Moran, L, Cramp, C, ewman, A, Kannieappian, L, Hendrijanto, S, Kelsey, M, Beaumont, J, Danz, C, Koch, J, Webber, A, Holst, C, Zhang, S, Ball, V, Ball, K, Salehi, N, Bartley, R, Stafford-Green, R, Ophel, S, Cooney, M, Szmeja, M, hort, A, Melrose, A, Han, S, Chapple, L, Svigos, J, Bhatia, V, Manton, N, McGavigan, J, Bryce, R, Coppi, S, Fanning, C, Hannah, G, Ignacio, M, Pollard, H, Schmidt, F, Shinners, Y, Dekker, G, Kennedy-Andrews, S, Beaven, R, Niven, J, Burgen, S, Dalton, J, Dewhurst, N, Forst, L, Mugg, V, Will, C, Stone, H, Wilkinson, C, Purcell, H, Wood, J, Press, D, Ralph, K, Donleavy, S, Seager, S, Gately, F, Jolly, A, Lahnstein, L, Harding, S, Daw, K, Hedges, M, and Fraser-Trumble, R

Published
2016
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11. Antenatal dietary and lifestyle advice for women who are overweight or obese and the effect on fetal growth and adiposity: the LIMIT randomised trial

Author

Grivell, R M, Yelland, L N, Deussen, A, Crowther, C A, Dodd, J M, Turnbull, D, McPhee, A, Gillman, M, Wittert, G, Owens, J A, Robinson, J S, Moran, L, Cramp, C, Newman, A, Kannieappan, L, Hendrijanto, S, Kelsey, M, Beaumont, J, Danz, C, Koch, J, Webber, A, Holst, C, Robinson, K, Zhang, S, Ball, V, Ball, K, Deussen, H, Salehi, N, Bartley, R, Stafford-Green, R, Ophel, S, Cooney, M, Szmeja, M, Short, A, Melrose, A, Han, S, Mohamad, I, Chapple, L, Earl, R, Staehr, C, Parange, N, Barreto, M, McGavigan, J, Bryce, R, Coppi, S, Fanning, C, Hannah, G, Ignacio, M, Pollard, H, Schmidt, F, Shinners, Y, Dekker, G, Kennedy-Andrews, S, Beaven, R, Niven, J, Burgen, S, Dalton, J, Dewhurst, N, Forst, L, Mugg, V, Will, C, Stone, H, Wilkinson, C, Purcell, H, Wood, J, Press, D, Ralph, K, Donleavy, S, Seager, S, Gately, F, Jolly, A, Lahnstein, L, Harding, S, Daw, K, Hedges, M, and Fraser-Trumble, R

Published
2016
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12. My Baby’s Movements: a stepped‐wedge cluster‐randomised controlled trial of a fetal movement awareness intervention to reduce stillbirths

Author

Flenady, V, primary, Gardener, G, additional, Ellwood, D, additional, Coory, M, additional, Weller, M, additional, Warrilow, KA, additional, Middleton, PF, additional, Wojcieszek, AM, additional, Groom, KM, additional, Boyle, FM, additional, East, C, additional, Lawford, HLS, additional, Callander, E, additional, Said, JM, additional, Walker, SP, additional, Mahomed, K, additional, Andrews, C, additional, Gordon, A, additional, Norman, JE, additional, and Crowther, C, additional

Published
2021
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15. A core outcome set for the treatment of pregnant women with pregestational diabetes: an international consensus study.

Author

Kgosidialwa O., Bogdanet D., Egan A.M., O'Shea P.M., Newman C., Griffin T.P., McDonagh C., O'Shea C., Carmody L., Cooray S.D., Anastasiou E., Wender-Ozegowska E., Clarson C., Spadola A., Alvarado F., Noctor E., Dempsey E., Napoli A., Crowther C., Galjaard S., Loeken M.R., Maresh M.J.A., Gillespie P., de Valk H., Agostini A., Biesty L., Devane D., Dunne F., Kgosidialwa O., Bogdanet D., Egan A.M., O'Shea P.M., Newman C., Griffin T.P., McDonagh C., O'Shea C., Carmody L., Cooray S.D., Anastasiou E., Wender-Ozegowska E., Clarson C., Spadola A., Alvarado F., Noctor E., Dempsey E., Napoli A., Crowther C., Galjaard S., Loeken M.R., Maresh M.J.A., Gillespie P., de Valk H., Agostini A., Biesty L., Devane D., and Dunne F.

Abstract

Objective: To develop a core outcome set (COS) for randomised controlled trials (RCTs) evaluating the effectiveness of interventions for the treatment of pregnant women with pregestational diabetes mellitus (PGDM). Design(s): A consensus developmental study. Setting(s): International. Population: Two hundred and five stakeholders completed the first round. Method(s): The study consisted of three components. (1) A systematic review of the literature to produce a list of outcomes reported in RCTs assessing the effectiveness of interventions for the treatment of pregnant women with PGDM. (2) A three-round, online eDelphi survey to prioritise these outcomes by international stakeholders (including healthcare professionals, researchers and women with PGDM). (3) A consensus meeting where stakeholders from each group decided on the final COS. Main Outcome Measure(s): All outcomes were extracted from the literature. Result(s): We extracted 131 unique outcomes from 67 records meeting the full inclusion criteria. Of the 205 stakeholders who completed the first round, 174/205 (85%) and 165/174 (95%) completed rounds 2 and 3, respectively. Participants at the subsequent consensus meeting chose 19 outcomes for inclusion into the COS: trimester-specific haemoglobin A1c, maternal weight gain during pregnancy, severe maternal hypoglycaemia, diabetic ketoacidosis, miscarriage, pregnancy-induced hypertension, pre-eclampsia, maternal death, birthweight, large for gestational age, small for gestational age, gestational age at birth, preterm birth, mode of birth, shoulder dystocia, neonatal hypoglycaemia, congenital malformations, stillbirth and neonatal death. Conclusion(s): This COS will enable better comparison between RCTs to produce robust evidence synthesis, improve trial reporting and optimise research efficiency in studies assessing treatment of pregnant women with PGDM. Tweetable abstract: 165 key stakeholders have developed #Treatment #CoreOutcomes in pregnant women with #diab

Published
2021

16. My Baby's Movements: a stepped-wedge cluster-randomised controlled trial of a fetal movement awareness intervention to reduce stillbirths

Author

Flenady, V, Gardener, G, Ellwood, D, Coory, M, Weller, M, Warrilow, KA, Middleton, PF, Wojcieszek, AM, Groom, KM, Boyle, FM, East, C, Lawford, HLS, Callander, E, Said, JM, Walker, SP, Mahomed, K, Andrews, C, Gordon, A, Norman, JE, Crowther, C, Flenady, V, Gardener, G, Ellwood, D, Coory, M, Weller, M, Warrilow, KA, Middleton, PF, Wojcieszek, AM, Groom, KM, Boyle, FM, East, C, Lawford, HLS, Callander, E, Said, JM, Walker, SP, Mahomed, K, Andrews, C, Gordon, A, Norman, JE, and Crowther, C

Abstract

OBJECTIVE: The My Baby's Movements (MBM) trial aimed to evaluate the impact on stillbirth rates of a multifaceted awareness package (the MBM intervention). DESIGN: Stepped-wedge cluster-randomised controlled trial. SETTING: Twenty-seven maternity hospitals in Australia and New Zealand. POPULATION: Women with a singleton pregnancy without major fetal anomaly at ≥28 weeks of gestation from August 2016 to May 2019. METHODS: The MBM intervention was implemented at randomly assigned time points, with the sequential introduction of eight groups of between three and five hospitals at 4-monthly intervals. Using generalised linear mixed models, the stillbirth rate was compared in the control and the intervention periods, adjusting for calendar time, study population characteristics and hospital effects. MAIN OUTCOME MEASURES: Stillbirth at ≥28 weeks of gestation. RESULTS: There were 304 850 births with 290 105 births meeting the inclusion criteria: 150 053 in the control and 140 052 in the intervention periods. The stillbirth rate was lower (although not statistically significantly so) during the intervention compared with the control period (2.2/1000 versus 2.4/1000 births; aOR 1.18, 95% CI 0.93-1.50; P = 0.18). The decrease in stillbirth rate was greater across calendar time: 2.7/1000 in the first versus 2.0/1000 in the last 18 months. No increase in secondary outcomes, including obstetric intervention or adverse neonatal outcome, was evident. CONCLUSIONS: The MBM intervention did not reduce stillbirths beyond the downward trend over time. As a result of low uptake, the role of the intervention remains unclear, although the downward trend across time suggests some benefit in lowering the stillbirth rate. In this study setting, an awareness of the importance of fetal movements may have reached pregnant women and clinicians prior to the implementation of the intervention. TWEETABLE ABSTRACT: The My Baby's Movements intervention to raise awareness of decreased fetal movement

Published
2021

18. Jack Kevorkian: A Medical Hero? Better Palliative Care Is The Answer

Author

Twycross, Robert, Gilbert, James, Crowther, C. A., Finlay, Ilora, Routledge, Philip, Freedma, Andrew, Woodhouse, Ken, Davies, D. P., Hawthorne, A. B., Pritchard, Mike, Hall, Molly, Beck, Peter, Wilkinson, Clare, Davis, Alison, Fergusson, Andrew, and Balfour, Robert P.

Published
1996

22. A core outcome set for studies of gestational diabetes mellitus prevention and treatment.

Author

van Poppel M.N.M., Thangaratinam S., Dunne F.P., Devane D., Biesty L.M., Crowther C., Egan A.M., Bogdanet D., Griffin T.P., Kgosidialwa O., Cervar-Zivkovic M., Dempsey E., Allotey J., Alvarado F., Clarson C., Cooray S.D., de Valk H.W., Galjaard S., Loeken M.R., Maresh M.J.A., Napoli A., O'Shea P.M., Wender-Ozegowska E., van Poppel M.N.M., Thangaratinam S., Dunne F.P., Devane D., Biesty L.M., Crowther C., Egan A.M., Bogdanet D., Griffin T.P., Kgosidialwa O., Cervar-Zivkovic M., Dempsey E., Allotey J., Alvarado F., Clarson C., Cooray S.D., de Valk H.W., Galjaard S., Loeken M.R., Maresh M.J.A., Napoli A., O'Shea P.M., and Wender-Ozegowska E.

Abstract

Aims/hypothesis: The aim of this systematic review was to develop core outcome sets (COSs) for trials evaluating interventions for the prevention or treatment of gestational diabetes mellitus (GDM). Method(s): We identified previously reported outcomes through a systematic review of the literature. These outcomes were presented to key stakeholders (including patient representatives, researchers and clinicians) for prioritisation using a three-round, e-Delphi study. A priori consensus criteria informed which outcomes were brought forward for discussion at a face-to-face consensus meeting where the COS was finalised. Result(s): Our review identified 74 GDM prevention and 116 GDM treatment outcomes, which were presented to stakeholders in round 1 of the e-Delphi study. Round 1 was completed by 173 stakeholders, 70% (121/173) of whom went on to complete round 2; 84% (102/121) of round 2 responders completed round 3. Twenty-two GDM prevention outcomes and 30 GDM treatment outcomes were discussed at the consensus meeting. Owing to significant overlap between included prevention and treatment outcomes, consensus meeting stakeholders agreed to develop a single prevention/treatment COS. Fourteen outcomes were included in the final COS. These consisted of six maternal outcomes (GDM diagnosis, adherence to the intervention, hypertensive disorders of pregnancy, requirement and type of pharmacological therapy for hyperglycaemia, gestational weight gain and mode of birth) and eight neonatal outcomes (birthweight, large for gestational age, small for gestational age, gestational age at birth, preterm birth, neonatal hypoglycaemia, neonatal death and stillbirth). Conclusions/interpretation: This COS will enable future GDM prevention and treatment trials to measure similar outcomes that matter to stakeholders and facilitate comparison and combination of these studies. Trial registration: This study was registered prospectively with the Core Outcome Measures in Effectiveness Trials (

Published
2020

23. A core outcome set for studies of gestational diabetes mellitus prevention and treatment

Author

Egan, A.M. (Aoife M.), Bogdanet, D. (Delia), Griffin, T.P. (Tomás P.), Kgosidialwa, O. (Oratile), Cervar-Zivkovic, M. (Mila), Dempsey, E. (Eugene), Allotey, J. (John), Alvarado, F. (Fernanda), Clarson, C. (Cheril), Cooray, S.D. (Shamil D.), Valk, H.W. (Harold) de, Galjaard, S. (Sander), Loeken, M.R. (Mary R.), Maresh, M.J.A. (Michael J. A.), Napoli, A. (Angela), O’Shea, P.M. (Paula M.), Wender-Ozegowska, E. (Ewa), Poppel, M.N. (Mireille) van, Thangaratinam, S. (Shakila), Crowther, C. (Caroline), Biesty, L.M. (Linda M.), Devane, D. (Declan), Dunne, F. (Fidelma), Egan, A.M. (Aoife M.), Bogdanet, D. (Delia), Griffin, T.P. (Tomás P.), Kgosidialwa, O. (Oratile), Cervar-Zivkovic, M. (Mila), Dempsey, E. (Eugene), Allotey, J. (John), Alvarado, F. (Fernanda), Clarson, C. (Cheril), Cooray, S.D. (Shamil D.), Valk, H.W. (Harold) de, Galjaard, S. (Sander), Loeken, M.R. (Mary R.), Maresh, M.J.A. (Michael J. A.), Napoli, A. (Angela), O’Shea, P.M. (Paula M.), Wender-Ozegowska, E. (Ewa), Poppel, M.N. (Mireille) van, Thangaratinam, S. (Shakila), Crowther, C. (Caroline), Biesty, L.M. (Linda M.), Devane, D. (Declan), and Dunne, F. (Fidelma)

Abstract

Aims/hypothesis: The aim of this systematic review was to develop core outcome sets (COSs) for trials evaluating interventions for the prevention or treatment of gestational diabetes mellitus (GDM). Methods: We identified previously reported outcomes through a systematic review of the literature. These outcomes were presented to key stakeholders (including patient representatives, researchers and clinicians) for prioritisation using a three-round, e-Delphi study. A priori consensus criteria informed which outcomes were brought forward for discussion at a face-to-face consensus meeting where the COS was finalised. Results: Our review identified 74 GDM prevention and 116 GDM treatment outcomes, which were presented to stakeholders in round 1 of the e-Delphi study. Round 1 was completed by 173 stakeholders, 70% (121/173) of whom went on to complete round 2; 84% (102/121) of round 2 responders completed round 3. Twenty-two GDM prevention outcomes and 30 GDM treatment outcomes were discussed at the consensus meeting. Owing to significant overlap between included prevention and treatment outcomes, consensus meeting stakeholders agreed to develop a single prevention/treatment COS. Fourteen outcomes were included in the final COS. These consisted of six maternal outcomes (GDM diagnosis, adherence to the intervention, hypertensive disorders of pregnancy, requirement and type of pharmacological therapy for hyperglycaemia, gestational weight gain and mode of birth) and eight neonatal outcomes (birthweight, large for gestational age, small for gestational age, gestational age at birth, preterm birth, neonatal hypoglycaemia, neonatal death and stillbirth). Conclusions/interpretation: This COS will enable future GDM prevention and treatment trials to measure similar outcomes that matter to stakeholders and facilitate comparison and combination of these studies. Trial registration: This study was registered prospectively with the Core Outcome Measures in Effectiveness Trials (COME

Published
2020
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24. A core outcome set for studies of gestational diabetes mellitus prevention and treatment

Author

Egan, AM, Bogdanet, D, Griffin, TP, Kgosidialwa, O, Cervar-Zivkovic, M, Dempsey, E, Allotey, J, Alvarado, F, Clarson, C, Cooray, SD, de Valk, HW, Galjaard, Sander, Loeken, MR, Maresh, MJA, Napoli, A, O’Shea, PM, Wender-Ozegowska, E, van Poppel, MN, Thangaratinam, S, Crowther, C, Biesty, LM, Devane, D, Dunne, FP, Egan, AM, Bogdanet, D, Griffin, TP, Kgosidialwa, O, Cervar-Zivkovic, M, Dempsey, E, Allotey, J, Alvarado, F, Clarson, C, Cooray, SD, de Valk, HW, Galjaard, Sander, Loeken, MR, Maresh, MJA, Napoli, A, O’Shea, PM, Wender-Ozegowska, E, van Poppel, MN, Thangaratinam, S, Crowther, C, Biesty, LM, Devane, D, and Dunne, FP

Published
2020

33. Sex-specific effects of nutritional supplements in infants born early or small: protocol for an individual participant data meta-analysis (ESSENCE IPD-MA)

Author

Lin, L., Crowther, C., Gamble, G., Bloomfield, F., Harding, J. E., Atkinson, S. A., Biasini, A., da Cunha, R. D. S., Embleton, N. D., Faraz, M., Fewtrell, M. S., Lamy Filho, F., Fusch, C., Gianni, M. L., Kanmaz, H. G., Koo, W. W. K., Litmanovitz, I., Lucas, A., Morgan, C., Mukhopadhyay, K., Neri, E., Picaud, J., Rafael, E. V., Roggero, P., Singhal, A., Stroemmen, K., Tan, M. J., Tandoi, F. M., Wood, C. L., Zachariassen, G., Agosti, M., Lin L., Crowther C., Gamble G., Bloomfield F., Harding J.E., Atkinson S.A., Biasini A., da Cunha R.D.S., Embleton N.D., Faraz M., Fewtrell M.S., Lamy Filho F., Fusch C., Gianni M.L., Kanmaz H.G., Koo W.W.K., Litmanovitz I., Lucas A., Morgan C., Mukhopadhyay K., Neri E., Picaud J., Rafael E.V., Roggero P., Singhal A., Stroemmen K., Tan M.J., Tandoi F.M., Wood C.L., and Zachariassen G.

Subjects
Pediatrics, medicine.medical_specialty, Infant, Premature, Diseases, Disease, development, individual participant data meta-analysis, metabolic, preterm, small-for-gestational-age, individual participant data meta-analysi, Diabetes mellitus, Cognitive development, Humans, Medicine, business.industry, Infant, Newborn, Paediatrics, General Medicine, medicine.disease, Obesity, Systematic review, Meta-analysis, Dietary Supplements, Infant, Small for Gestational Age, Small for gestational age, business, Body mass index
Abstract

IntroductionPreterm and small for gestational age (SGA) infants are at increased risk of poor growth, disability and delayed development. While growing up they are also at increased risk of obesity, diabetes and later heart disease. The risk of such adverse outcomes may be altered by how preterm and SGA infants are fed after birth. Faltering postnatal growth is common due to failure to achieve recommended high energy and protein intakes, and thus preterm and SGA infants are often provided with supplemental nutrition soon after birth. Enhanced nutrition has been associated with improved early growth and better cognitive development. However, limited evidence suggests that faster growth may increase the risk for later adiposity, metabolic and cardiovascular disease, and that such risks may differ between girls and boys.Methods and analysisWe will search Ovid MEDLINE, Embase, Cochrane CENTRAL, Cochrane Database of Systematic Reviews, controlled-trials.com, ClinicalTrials.gov and anzctr.org.au for randomised trials that studied the effects of macronutrient supplements for preterm and SGA infants on (i) developmental and metabolic and (ii) growth outcomes after hospital discharge. The outcomes will be (i) cognitive impairment and metabolic risk (co-primary) and (ii) body mass index. Individual participant data (IPD) from all available trials will be included using an intention-to-treat approach. A one-stage procedure for IPD meta-analysis (MA) will be used, accounting for clustering of participants within studies. Exploratory subgroup analyses will further investigate sources of heterogeneity, including sex and size of infants, different timing, duration and type of supplements.Ethics and disseminationThis IPD-MA is approved by the University of Auckland Human Participants Ethics Committee (reference number: 019874). Individual studies have approval from relevant local ethics committees. Results will be disseminated in a peer-reviewed journal and presented at international conferences.PROSPERO registration numberCRD42017072683

Published
2020

36. Maternal intramuscular dexamethasone versus betamethasone before preterm birth (ASTEROID): a multicentre, double-blind, randomised controlled trial

Author

Crowther, CA, Ashwood, P, Andersen, CC, Middleton, PF, Tran, T, Doyle, LW, Robinson, JS, Harding, JE, Crowther, C, Ball, V, Holst, C, Robinson, K, Zhang, S, Robinson, J, Khong, Y, McPhee, A, Groom, K, Alsweiler, J, Eaglen, D, Hauch, H, Vallely, A, Angus, S, Chenia, F, Drew, A, Gavranich, J, Green, A, Jack, S, Mahomed, K, Sebastian, R, Turner, L, Baldwin, M, Dennis, A, Fisher, E, Gee, K, Gee, M, Strong, D, Boord, D, Edge, N, Marsh, M, Staehr, C, Chaplin, J, Gardener, G, Gray, P, Hurrion, E, Jardine, L, Kan, J, Lynn, L, Poulsen, L, Tremellen, A, Codner, T, Cubis, W, Downward, S, Dunn, C, Furey, J, Hansen, D, Lampropoulos, B, Masson, E, Peek, M, Sellar, S, Butterley, K, Chadwick, M, Davis, C, DePaoli, T, Green, L, Matzolic, T, Woodhead, G, Biggs, V, Henry, A, Lainchbury, A, Nesbitt-Hawes, E, Oei, JL, Rodrigues, C, Shand, A, Sutton, L, Welsh, A, Bowen, J, Hayes-Cameron, L, Howard, G, Jacobs, C, Milligan, J, Morris, J, Rickard, K, Sedgley, J, White-Matthews, K, Blandthorn, J, Brownfoot, F, Burnett, A, Callanan, K, Davis, N, Deluca, C, Duff, J, Howard, K, Hutchinson, E, Kelly, E, Kornman, L, Kuschel, C, Maxwell, D, McDonald, M, Poth, M, Co, J, Crowther, CA, Ashwood, P, Andersen, CC, Middleton, PF, Tran, T, Doyle, LW, Robinson, JS, Harding, JE, Crowther, C, Ball, V, Holst, C, Robinson, K, Zhang, S, Robinson, J, Khong, Y, McPhee, A, Groom, K, Alsweiler, J, Eaglen, D, Hauch, H, Vallely, A, Angus, S, Chenia, F, Drew, A, Gavranich, J, Green, A, Jack, S, Mahomed, K, Sebastian, R, Turner, L, Baldwin, M, Dennis, A, Fisher, E, Gee, K, Gee, M, Strong, D, Boord, D, Edge, N, Marsh, M, Staehr, C, Chaplin, J, Gardener, G, Gray, P, Hurrion, E, Jardine, L, Kan, J, Lynn, L, Poulsen, L, Tremellen, A, Codner, T, Cubis, W, Downward, S, Dunn, C, Furey, J, Hansen, D, Lampropoulos, B, Masson, E, Peek, M, Sellar, S, Butterley, K, Chadwick, M, Davis, C, DePaoli, T, Green, L, Matzolic, T, Woodhead, G, Biggs, V, Henry, A, Lainchbury, A, Nesbitt-Hawes, E, Oei, JL, Rodrigues, C, Shand, A, Sutton, L, Welsh, A, Bowen, J, Hayes-Cameron, L, Howard, G, Jacobs, C, Milligan, J, Morris, J, Rickard, K, Sedgley, J, White-Matthews, K, Blandthorn, J, Brownfoot, F, Burnett, A, Callanan, K, Davis, N, Deluca, C, Duff, J, Howard, K, Hutchinson, E, Kelly, E, Kornman, L, Kuschel, C, Maxwell, D, McDonald, M, Poth, M, and Co, J

Abstract

Background: Antenatal corticosteroids given to women before preterm birth improve infant survival and health. However, whether dexamethasone or betamethasone have better maternal, neonatal, and childhood health outcomes remains unclear. We therefore aimed to assess whether administration of antenatal dexamethasone to women at risk of preterm birth reduced the risk of death or neurosensory disability in their children at age 2 years compared with betamethasone. We also aimed to assess whether dexamethasone reduced neonatal morbidity, had benefits for the mother, or affected childhood body size, blood pressure, behaviour, or general health compared with betamethasone. Methods: In this multicentre, double-blind, randomised controlled trial, we recruited pregnant women from 14 maternity hospitals in Australia and New Zealand that could provide care to preterm babies. Women were eligible for study inclusion if they were at risk of preterm birth before 34 weeks of gestation, had a singleton or twin pregnancy, and had no contraindications to antenatal corticosteroids. We randomly assigned women (1:1) to receive two intramuscular injections of either 12 mg dexamethasone (dexamethasone sodium phosphate) or 11·4 mg betamethasone (Celestone Chronodose), 24 h apart. The randomisation schedule used balanced, variable blocks that were stratified by hospital, gestational age, and number of fetuses (singleton or twins). We masked all participants, staff, and assessors to treatment groups. Analyses were by intention to treat. The primary outcome was death or neurosensory disability at age 2 years (corrected for prematurity). This study is registered with ANZCTR, ACTRN12608000631303. Findings: Between Jan 28, 2009, and Feb 1, 2013, we randomly assigned 1346 (78%) women who were pregnant with 1509 fetuses to groups: 679 (50%) women were assigned to receive dexamethasone and 667 (50%) women were assigned to receive betamethasone. 27 (4%) fetuses, infants, or children in the dexamethaso

Published
2019

37. Follow-up at 1 year and beyond of women with gestational diabetes treated with insulin and/or oral glucose-lowering agents: a core outcome set using a Delphi survey

Author

Bogdanet, D. (Delia), Reddin, C. (Catriona), Macken, E. (Esther), Griffin, T.P. (Tomas P.), Fhelelboom, N. (Narjes), Biesty, L. (Linda), Thangaratinam, S. (Shakila), Dempsey, E. (Eugene), Crowther, C. (Caroline), Galjaard, S. (Sander), Maresh, M. (Michael), Loeken, M.R. (Mary R.), Napoli, A. (Angela), Anastasiou, E. (Eleni), Noctor, E. (Eoin), Valk, H.W. (Harold) de, Poppel, M.N. (Mireille) van, Agostini, A. (Andrea), Clarson, C. (Cheril), Egan, A.M. (Aoife M.), O’Shea, P.M. (Paula M.), Devane, D. (Declan), Dunne, F. (Fidelma), Bogdanet, D. (Delia), Reddin, C. (Catriona), Macken, E. (Esther), Griffin, T.P. (Tomas P.), Fhelelboom, N. (Narjes), Biesty, L. (Linda), Thangaratinam, S. (Shakila), Dempsey, E. (Eugene), Crowther, C. (Caroline), Galjaard, S. (Sander), Maresh, M. (Michael), Loeken, M.R. (Mary R.), Napoli, A. (Angela), Anastasiou, E. (Eleni), Noctor, E. (Eoin), Valk, H.W. (Harold) de, Poppel, M.N. (Mireille) van, Agostini, A. (Andrea), Clarson, C. (Cheril), Egan, A.M. (Aoife M.), O’Shea, P.M. (Paula M.), Devane, D. (Declan), and Dunne, F. (Fidelma)

Abstract

Aims/hypothesis: Gestational diabetes mellitus (GDM) is linked with a higher lifetime risk for the development of impaired fasting glucose, impaired glucose tolerance, type 2 diabetes, the metabolic syndrome, cardiovascular disease, postpartum depression and tumours. Despite this, there is no consistency in the long-term follow-up of women with a previous diagnosis of GDM. Further, the outcomes selected and reported in the research involving this population are heterogeneous and lack standardisation. This amplifies the risk of reporting bias and diminishes the likelihood of significant comparisons between studies. The

Published
2019
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38. My Baby's Movements: a stepped wedge cluster randomised controlled trial to raise maternal awareness of fetal movements during pregnancy study protocol

Author

Flenady, V, Gardener, G, Boyle, FM, Callander, E, Coory, M, East, C, Ellwood, D, Gordon, A, Groom, KM, Middleton, PF, Norman, JE, Warrilow, KA, Weller, M, Wojcieszek, AM, Crowther, C, Flenady, V, Gardener, G, Boyle, FM, Callander, E, Coory, M, East, C, Ellwood, D, Gordon, A, Groom, KM, Middleton, PF, Norman, JE, Warrilow, KA, Weller, M, Wojcieszek, AM, and Crowther, C

Abstract

BACKGROUND: Stillbirth is a devastating pregnancy outcome that has a profound and lasting impact on women and families. Globally, there are over 2.6 million stillbirths annually and progress in reducing these deaths has been slow. Maternal perception of decreased fetal movements (DFM) is strongly associated with stillbirth. However, maternal awareness of DFM and clinical management of women reporting DFM is often suboptimal. The My Baby's Movements trial aims to evaluate an intervention package for maternity services including a mobile phone application for women and clinician education (MBM intervention) in reducing late gestation stillbirth rates. METHODS/DESIGN: This is a stepped wedge cluster randomised controlled trial with sequential introduction of the MBM intervention to 8 groups of 3-5 hospitals at four-monthly intervals over 3 years. The target population is women with a singleton pregnancy, without lethal fetal abnormality, attending for antenatal care and clinicians providing maternity care at 26 maternity services in Australia and New Zealand. The primary outcome is stillbirth from 28 weeks' gestation. Secondary outcomes address: a) neonatal morbidity and mortality; b) maternal psychosocial outcomes and health-seeking behaviour; c) health services utilisation; d) women's and clinicians' knowledge of fetal movements; and e) cost. 256,700 births (average of 3170 per hospital) will detect a 30% reduction in stillbirth rates from 3/1000 births to 2/1000 births, assuming a significance level of 5%. Analysis will utilise generalised linear mixed models. DISCUSSION: Maternal perception of DFM is a marker of an at-risk pregnancy and commonly precedes a stillbirth. MBM offers a simple, inexpensive resource to reduce the number of stillborn babies, and families suffering the distressing consequences of such a loss. This large pragmatic trial will provide evidence on benefits and potential harms of raising awareness of DFM using a mobile phone app. TRIAL REGISTRAT

Published
2019

39. Effects of repeat prenatal corticosteroids given to women at risk of preterm birth:an individual participant data meta-analysis

Author

Crowther, C. A. (Caroline A.), Middleton, P. F. (Philippa F.), Voysey, M. (Merryn), Askie, L. (Lisa), Zhang, S. (Sasha), Martlow, T. K. (Tanya K.), Aghajafari, F. (Fariba), Asztalos, E. V. (Elizabeth V.), Brocklehurst, P. (Peter), Dutta, S. (Sourabh), Garite, T. J. (Thomas J.), Guinn, D. A. (Debra A.), Hallman, M. (Mikko), Hardy, P. (Pollyanna), Lee, M.-J. (Men-Jean), Maurel, K. (Kimberley), Mazumder, P. (Premasish), McEvoy, C. (Cindy), Murphy, K. E. (Kellie E.), Peltoniemi, O. M. (Outi M.), Thom, E. A. (Elizabeth A.), Wapner, R. J. (Ronald J.), Doyle, L. W. (Lex W.), Crowther, C. A. (Caroline A.), Middleton, P. F. (Philippa F.), Voysey, M. (Merryn), Askie, L. (Lisa), Zhang, S. (Sasha), Martlow, T. K. (Tanya K.), Aghajafari, F. (Fariba), Asztalos, E. V. (Elizabeth V.), Brocklehurst, P. (Peter), Dutta, S. (Sourabh), Garite, T. J. (Thomas J.), Guinn, D. A. (Debra A.), Hallman, M. (Mikko), Hardy, P. (Pollyanna), Lee, M.-J. (Men-Jean), Maurel, K. (Kimberley), Mazumder, P. (Premasish), McEvoy, C. (Cindy), Murphy, K. E. (Kellie E.), Peltoniemi, O. M. (Outi M.), Thom, E. A. (Elizabeth A.), Wapner, R. J. (Ronald J.), and Doyle, L. W. (Lex W.)

Abstract

Background: Infants born preterm compared with infants born at term are at an increased risk of dying and of serious morbidities in early life, and those who survive have higher rates of neurological impairments. It remains unclear whether exposure to repeat courses of prenatal corticosteroids can reduce these risks. This individual participant data (IPD) meta-analysis (MA) assessed whether repeat prenatal corticosteroid treatment given to women at ongoing risk of preterm birth in order to benefit their infants is modified by participant or treatment factors. Methods and findings: Trials were eligible for inclusion if they randomised women considered at risk of preterm birth who had already received an initial, single course of prenatal corticosteroid seven or more days previously and in which corticosteroids were compared with either placebo or no placebo. The primary outcomes for the infants were serious outcome, use of respiratory support, and birth weight z-scores; for the children, they were death or any neurosensory disability; and for the women, maternal sepsis. Studies were identified using the Cochrane Pregnancy and Childbirth search strategy. Date of last search was 20 January 2015. IPD were sought from investigators with eligible trials. Risk of bias was assessed using criteria from the Cochrane Collaboration. IPD were analysed using a one-stage approach. Eleven trials, conducted between 2002 and 2010, were identified as eligible, with five trials being from the United States, two from Canada, and one each from Australia and New Zealand, Finland, India, and the United Kingdom. All 11 trials were included, with 4,857 women and 5,915 infants contributing data. The mean gestational age at trial entry for the trials was between 27.4 weeks and 30.2 weeks. There was no significant difference in the proportion of infants with a serious outcome (relative risk [RR] 0.92, 95% confidence interval [CI] 0.82 to 1.04, 5,893 infants, 11 trials, p = 0.33 for het

Published
2019

40. Follow-up at 1 year and beyond of women with gestational diabetes treated with insulin and/or oral glucose-lowering agents: a core outcome set using a Delphi survey

Author

Bogdanet, D, Reddin, C, Macken, E, Griffin, TP, Fhelelboom, N, Biesty, L, Thangaratinam, S, Dempsey, E, Crowther, C, Galjaard, Sander, Maresh, M, Loeken, MR, Napoli, A, Anastasiou, E, Noctor, E, de Valk, HW, van Poppel, MN, Agostini, A, Clarson, C, Egan, AM, O'Shea, PM, Devane, D, Dunne, FP, Bogdanet, D, Reddin, C, Macken, E, Griffin, TP, Fhelelboom, N, Biesty, L, Thangaratinam, S, Dempsey, E, Crowther, C, Galjaard, Sander, Maresh, M, Loeken, MR, Napoli, A, Anastasiou, E, Noctor, E, de Valk, HW, van Poppel, MN, Agostini, A, Clarson, C, Egan, AM, O'Shea, PM, Devane, D, and Dunne, FP

Published
2019

41. Beyond the headlines: Fetal movement awareness is an important stillbirth prevention strategy

Author

Flenady, V, Ellwood, D, Bradford, B, Coory, M, Middleton, P, Gardener, G, Radestad, I, Homer, C, Davies-Tuck, M, Forster, D, Gordon, A, Groom, K, Crowther, C, Walker, S, Foord, C, Warland, J, Murphy, M, Said, J, Boyle, F, O'Donoghue, K, Cronin, R, Sexton, J, Weller, M, McCowan, L, Flenady, V, Ellwood, D, Bradford, B, Coory, M, Middleton, P, Gardener, G, Radestad, I, Homer, C, Davies-Tuck, M, Forster, D, Gordon, A, Groom, K, Crowther, C, Walker, S, Foord, C, Warland, J, Murphy, M, Said, J, Boyle, F, O'Donoghue, K, Cronin, R, Sexton, J, Weller, M, and McCowan, L

Published
2019

42. A core outcome set for the treatment of pregnant women with pregestational diabetes: an international consensus study.

Author

Kgosidialwa, O, Bogdanet, D, Egan, AM, O'Shea, PM, Newman, C, Griffin, TP, McDonagh, C, O'Shea, C, Carmody, L, Cooray, SD, Anastasiou, E, Wender‐Ozegowska, E, Clarson, C, Spadola, A, Alvarado, F, Noctor, E, Dempsey, E, Napoli, A, Crowther, C, and Galjaard, S

Abstract

Objective: To develop a core outcome set (COS) for randomised controlled trials (RCTs) evaluating the effectiveness of interventions for the treatment of pregnant women with pregestational diabetes mellitus (PGDM). Design: A consensus developmental study. Setting: International. Population: Two hundred and five stakeholders completed the first round. Methods: The study consisted of three components. (1) A systematic review of the literature to produce a list of outcomes reported in RCTs assessing the effectiveness of interventions for the treatment of pregnant women with PGDM. (2) A three‐round, online eDelphi survey to prioritise these outcomes by international stakeholders (including healthcare professionals, researchers and women with PGDM). (3) A consensus meeting where stakeholders from each group decided on the final COS. Main outcome measures: All outcomes were extracted from the literature. Results: We extracted 131 unique outcomes from 67 records meeting the full inclusion criteria. Of the 205 stakeholders who completed the first round, 174/205 (85%) and 165/174 (95%) completed rounds 2 and 3, respectively. Participants at the subsequent consensus meeting chose 19 outcomes for inclusion into the COS: trimester‐specific haemoglobin A1c, maternal weight gain during pregnancy, severe maternal hypoglycaemia, diabetic ketoacidosis, miscarriage, pregnancy‐induced hypertension, pre‐eclampsia, maternal death, birthweight, large for gestational age, small for gestational age, gestational age at birth, preterm birth, mode of birth, shoulder dystocia, neonatal hypoglycaemia, congenital malformations, stillbirth and neonatal death. Conclusions: This COS will enable better comparison between RCTs to produce robust evidence synthesis, improve trial reporting and optimise research efficiency in studies assessing treatment of pregnant women with PGDM. 165 key stakeholders have developed #Treatment #CoreOutcomes in pregnant women with #diabetes existing before pregnancy. 165 key stakeholders have developed #Treatment #CoreOutcomes in pregnant women with #diabetes existing before pregnancy. [ABSTRACT FROM AUTHOR]

Published
2021
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47. Suction v. conventional curettage in incomplete abortion A randomised controlled trial

Author

Verkuyl, D. A. A. and Crowther, C. A.

Abstract

This randomised controlled trial of 357 patients who had had an incomplete abortion compared suction curettage with conventional curettage for evacuation ofthe uterus. The 179 patients undergoing suction curettage had a significantly lower intra-operative blood loss (P < 0,0001) and a significantly higher mean haemoglobin level at follow-up compared with the 178 patients who had conventional curettage. Suction curettage was a faster procedure and less painful. No difference was found between the two groups with regard to the incidence ofpost-abortal sepsis, or the re-evacuation rate. No problems were encountered with the use of suction curettage in the presence of uterine sepsis. In an era where blood transfusions should be kept to an absolute minimum, suction curettage will help to save blood in several ways.

Published
2017

48. The VLT-FLAMES Tarantula Survey

Author

O. H. Ramírez-Agudelo, H. Sana, A. de Koter, F. Tramper, N. J. Grin, F. R. N. Schneider, N. Langer, J. Puls, N. Markova, J. M. Bestenlehner, N. Castro, P. A. Crowther, C. J. Evans, M. García, G. Gräfener, A. Herrero, B. van Kempen, D. J. Lennon, J. Maíz Apellániz, F. Najarro, C. Sabín-Sanjulián, S. Simón-Díaz, W. D. Taylor, J. S. Vink

Published
2017
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49. The 'Corpus of Ptolemaic Inscriptions from Egypt' project: Unpublished texts

Author

Bowman, A, Crowther, C, and Savvopoulos, K

Abstract

We here offer fi rst editions of six short inscriptions which will be included in the forthcoming first part of the Corpus of Ptolemaic Inscriptions. This will contain almost 600 bilingual and trilingual texts from Egypt, based on material collected and annotated by P. M. Fraser (1918–2007). The project is based at the Centre for the Study of Ancient Documents (CSAD), University of Oxford, and is funded by the Arts and Humanities Research Council of England and Wales.

Published
2016

50. Antenatal corticosteroids for women at risk of imminent preterm birth in low-resource countries: the case for equipoise and the need for efficacy trials

Author

Vogel, JP, Oladapo, OT, Pileggi-Castro, C, Adejuyigbe, EA, Althabe, F, Ariff, S, Ayede, AI, Baqui, AH, Costello, A, Chikamata, DM, Crowther, C, Fawole, B, Gibbons, L, Jobe, AH, Kapasa, ML, Kinuthia, J, Kriplani, A, Kuti, O, Neilson, J, Patterson, J, Piaggio, G, Qureshi, R, Qureshi, Z, Sankar, MJ, Stringer, JSA, Temmerman, M, Yunis, K, Bahl, R, Gulmezoglu, AM, Vogel, JP, Oladapo, OT, Pileggi-Castro, C, Adejuyigbe, EA, Althabe, F, Ariff, S, Ayede, AI, Baqui, AH, Costello, A, Chikamata, DM, Crowther, C, Fawole, B, Gibbons, L, Jobe, AH, Kapasa, ML, Kinuthia, J, Kriplani, A, Kuti, O, Neilson, J, Patterson, J, Piaggio, G, Qureshi, R, Qureshi, Z, Sankar, MJ, Stringer, JSA, Temmerman, M, Yunis, K, Bahl, R, and Gulmezoglu, AM

Abstract

The scientific basis for antenatal corticosteroids (ACS) for women at risk of preterm birth has rapidly changed in recent years. Two landmark trials-the Antenatal Corticosteroid Trial and the Antenatal Late Preterm Steroids Trial-have challenged the long-held assumptions on the comparative health benefits and harms regarding the use of ACS for preterm birth across all levels of care and contexts, including resource-limited settings. Researchers, clinicians, programme managers, policymakers and donors working in low-income and middle-income countries now face challenging questions of whether, where and how ACS can be used to optimise outcomes for both women and preterm newborns. In this article, we briefly present an appraisal of the current evidence around ACS, how these findings informed WHO's current recommendations on ACS use, and the knowledge gaps that have emerged in the light of new trial evidence. Critical considerations in the generalisability of the available evidence demonstrate that a true state of clinical equipoise exists for this treatment option in low-resource settings. An expert group convened by WHO concluded that there is a clear need for more efficacy trials of ACS in these settings to inform clinical practice.

Published
2017

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