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1. Maternal Mid-Gestation Cytokine Dysregulation in Mothers of Children with Autism Spectrum Disorder

Author

Casey, S., Carter, M., Looney, A. M., Livingstone, V., Moloney, G., O'Keeffe, G. W., Taylor, R. S., Kenny, L. C., McCarthy, F. P., McCowan, L. M. E., Thompson, J. M. D., and Murray, D. M.

Abstract

Autism spectrum disorder (ASD) is a developmental disorder characterised by deficits in social interactions and communication, with stereotypical and repetitive behaviours. Recent evidence suggests that maternal immune dysregulation may predispose offspring to ASD. Independent samples t-tests revealed downregulation of IL-17A concentrations in cases, when compared to controls, at both 15 weeks (p = 0.02), and 20 weeks (p = 0.02), which persisted at 20 weeks following adjustment for confounding variables. This adds to the growing body of evidence that maternal immune regulation may play a role in foetal neurodevelopment. [This article was written on behalf of the SCOPE Consortium.]

Published
2022
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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

5. 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
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6. Enoxaparin for the prevention of preeclampsia and intrauterine growth restriction in women with a history: a randomized trial

Author

Groom, Katie M., McCowan, Lesley M., Mackay, Laura K., Lee, Arier C., Said, Joanne M., Kane, Stefan C., Walker, Susan P., van Mens, Thijs E., Hannan, Natalie J., Tong, Stephen, Chamley, Larry W., Stone, Peter R., McLintock, Claire, Groom, K., McCowan, L., Mackay, L., Lee, A., Stone, P., Chamley, L., McLintock, C., Said, J., Kane, S., Walker, S., Tong, S., Hannan, N., van Mens, T., Ganzevoort, W., and Middeldorp, S.

Published
2017
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8. Evaluation of the Growth Assessment Protocol (GAP) for antenatal detection of small for gestational age: The DESiGN cluster randomised trial.

Author

Vieira, MC, Relph, S, Muruet-Gutierrez, W, Elstad, M, Coker, B, Moitt, N, Delaney, L, Winsloe, C, Healey, A, Coxon, K, Alagna, A, Briley, A, Johnson, M, Page, LM, Peebles, D, Shennan, A, Thilaganathan, B, Marlow, N, McCowan, L, Lees, C, Lawlor, DA, Khalil, A, Sandall, J, Copas, A, Pasupathy, D, DESiGN Collaborative Group, Vieira, MC, Relph, S, Muruet-Gutierrez, W, Elstad, M, Coker, B, Moitt, N, Delaney, L, Winsloe, C, Healey, A, Coxon, K, Alagna, A, Briley, A, Johnson, M, Page, LM, Peebles, D, Shennan, A, Thilaganathan, B, Marlow, N, McCowan, L, Lees, C, Lawlor, DA, Khalil, A, Sandall, J, Copas, A, Pasupathy, D, and DESiGN Collaborative Group

Abstract

BACKGROUND: Antenatal detection and management of small for gestational age (SGA) is a strategy to reduce stillbirth. Large observational studies provide conflicting results on the effect of the Growth Assessment Protocol (GAP) in relation to detection of SGA and reduction of stillbirth; to the best of our knowledge, there are no reported randomised control trials. Our aim was to determine if GAP improves antenatal detection of SGA compared to standard care. METHODS AND FINDINGS: This was a pragmatic, superiority, 2-arm, parallel group, open, cluster randomised control trial. Maternity units in England were eligible to participate in the study, except if they had already implemented GAP. All women who gave birth in participating clusters (maternity units) during the year prior to randomisation and during the trial (November 2016 to February 2019) were included. Multiple pregnancies, fetal abnormalities or births before 24+1 weeks were excluded. Clusters were randomised to immediate implementation of GAP, an antenatal care package aimed at improving detection of SGA as a means to reduce the rate of stillbirth, or to standard care. Randomisation by random permutation was stratified by time of study inclusion and cluster size. Data were obtained from hospital electronic records for 12 months prerandomisation, the washout period (interval between randomisation and data collection of outcomes), and the outcome period (last 6 months of the study). The primary outcome was ultrasound detection of SGA (estimated fetal weight <10th centile using customised centiles (intervention) or Hadlock centiles (standard care)) confirmed at birth (birthweight <10th centile by both customised and population centiles). Secondary outcomes were maternal and neonatal outcomes, including induction of labour, gestational age at delivery, mode of birth, neonatal morbidity, and stillbirth/perinatal mortality. A 2-stage cluster-summary statistical approach calculated the absolute difference (inter

Published
2022

9. Effect of the Growth Assessment Protocol on the DEtection of Small for GestatioNal age fetus: process evaluation from the DESiGN cluster randomised trial.

Author

Relph, S, Coxon, K, Vieira, MC, Copas, A, Healey, A, Alagna, A, Briley, A, Johnson, M, Lawlor, DA, Lees, C, Marlow, N, McCowan, L, McMicking, J, Page, L, Peebles, D, Shennan, A, Thilaganathan, B, Khalil, A, Pasupathy, D, Sandall, J, DESiGN Collaborative Group, Relph, S, Coxon, K, Vieira, MC, Copas, A, Healey, A, Alagna, A, Briley, A, Johnson, M, Lawlor, DA, Lees, C, Marlow, N, McCowan, L, McMicking, J, Page, L, Peebles, D, Shennan, A, Thilaganathan, B, Khalil, A, Pasupathy, D, Sandall, J, and DESiGN Collaborative Group

Abstract

BACKGROUND: Reducing the rate of stillbirth is an international priority. At least half of babies stillborn in high-income countries are small for gestational-age (SGA). The Growth Assessment Protocol (GAP), a complex antenatal intervention that aims to increase the rate of antenatal detection of SGA, was evaluated in the DESiGN type 2 hybrid effectiveness-implementation cluster randomised trial (n = 13 clusters). In this paper, we present the trial process evaluation. METHODS: A mixed-methods process evaluation was conducted. Clinical leads and frontline healthcare professionals were interviewed to inform understanding of context (implementing and standard care sites) and GAP implementation (implementing sites). Thematic analysis of interview text used the context and implementation of complex interventions framework to understand acceptability, feasibility, and the impact of context. A review of implementing cluster clinical guidelines, training and maternity records was conducted to assess fidelity, dose and reach. RESULTS: Interviews were conducted with 28 clinical leads and 27 frontline healthcare professionals across 11 sites. Staff at implementing sites generally found GAP to be acceptable but raised issues of feasibility, caused by conflicting demands on resource, and variable beliefs among clinical leaders regarding the intervention value. GAP was implemented with variable fidelity (concordance of local guidelines to GAP was high at two sites, moderate at two and low at one site), all sites achieved the target to train > 75% staff using face-to-face methods, but only one site trained > 75% staff using e-learning methods; a median of 84% (range 78-87%) of women were correctly risk stratified at the five implementing sites. Most sites achieved high scores for reach (median 94%, range 62-98% of women had a customised growth chart), but generally, low scores for dose (median 31%, range 8-53% of low-risk women and median 5%, range 0-17% of high-risk women) were

Published
2022

10. Rainfall

Author

Mbuya, O.S., primary, Tsegaye, T.D., additional, and McCowan, L., additional

Published
2015
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14. External validation of prognostic models to predict stillbirth using International Prediction of Pregnancy Complications ( <scp>IPPIC</scp> ) Network database: individual participant data meta‐analysis

Author

Allotey, J, Whittle, R, Snell, KIE, Smuk, M, Townsend, R, Dadelszen, P, Heazell, AEP, Magee, L, Smith, GCS, Sandall, J, Thilaganathan, B, Zamora, J, Riley, RD, Khalil, A, Thangaratinam, S, Coomarasamy, A, Kwong, A, Savitri, AI, Salvesen, KÅ, Bhattacharya, S, Uiterwaal, CSPM, Staff, AC, Andersen, LB, Olive, EL, Redman, C, Sletner, L, Daskalakis, G, Macleod, M, Abdollahain, M, Ramírez, JA, Massé, J, Audibert, F, Magnus, PM, Jenum, AK, Baschat, A, Ohkuchi, A, McAuliffe, FM, West, J, Askie, LM, Mone, F, Farrar, D, Zimmerman, PA, Smits, LJM, Riddell, C, Kingdom, JC, Post, J, Illanes, SE, Holzman, C, Kuijk, SMJ, Carbillon, L, Villa, PM, Eskild, A, Chappell, L, Prefumo, F, Velauthar, L, Seed, P, Oostwaard, M, Verlohren, S, Poston, L, Ferrazzi, E, Vinter, CA, Nagata, C, Brown, M, Vollebregt, KC, 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, JE, Figueiró‐Filho, EA, Lapaire, O, Laivuori, H, Lykke, JA, Conde‐Agudelo, A, Galindo, A, Mbah, A, Betran, AP, Herraiz, I, Trogstad, L, Smith, GGS, Steegers, EAP, Salim, R, Huang, T, Adank, A, Zhang, J, Meschino, WS, Browne, JL, Allen, RE, Costa, F Da Silva, Klipstein‐Grobusch, K, Crowther, CA, Jørgensen, JS, Forest, J‐C, Rumbold, AR, Mol, BW, Giguère, Y, Kenny, LC, Ganzevoort, W, Odibo, AO, Myers, J, Yeo, SA, Goffinet, F, McCowan, L, Pajkrt, E, Teede, HJ, Haddad, BG, Dekker, G, Kleinrouweler, EC, LeCarpentier, É, Roberts, CT, Groen, H, Skråstad, RB, Heinonen, S, Eero, K, Anggraini, D, Souka, A, Cecatti, JG, Monterio, I, Pillalis, A, Souza, R, Hawkins, LA, 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 risk can guide decisions on closer surveillance or timing of birth to prevent fetal death.Prognostic models have been developed to predict the risk of stillbirth, but none have yet been externally validated. We externally validated published prediction models for stillbirth using individual participant data (IPD) meta-analysis to assess their predictive performance. Methods: We searched Medline, EMBASE, DH-DATA and AMED databases from inception to December 2020 to identify stillbirth prediction models. We included studies that developed or updated prediction models for stillbirth for use at any time during pregnancy. IPD from cohorts within the International Prediction of Pregnancy Complication (IPPIC) Network were used to externally validate the identified prediction models whose individual variables were available in the IPD. We assessed the risk of bias of the models and IPD using PROBAST, and reported discriminative performance using the C-statistic, and calibration performance using calibration plots, calibration slopeand calibration-in-the-large. We estimated performance measures separately in each study, and then summarised across studies using random-effects meta-analysis. Clinical utility was assessed using net benefit. Results: We identified 17 studies reporting the development of 40 prognostic models for stillbirth. None of the models were previously externally validated, and only a fifth (20%, 8/40) reported the full model equation. We were able to validate three of these models using the IPD from 19 cohort studies (491,201 pregnant women) within the IPPIC Network database. Based on evaluating their development studies, all three models had an overall high risk of bias according to PROBAST. In our IPD meta-analysis, the models had summary C-statistics ranging from 0.53 to 0.65; summary calibration slopes of 0.40to 0.88, and generally with observed risks predictions that were too extreme compared to observed risks; and little to no clinical utility as assessed by net benefit. However, there remained uncertainty in performance for some models due to small available sample sizes. Conclusion: The three validated models generally showed poor and uncertain predictive performancein new data, with limited evidence to support their clinical application. Findings suggest methodological shortcomings in their development including overfitting of models. Further research is needed to further validate these and other models, identify stronger prognostic factors, and to develop more robust prediction models

Published
2021

27. The DESiGN trial (DEtection of Small for Gestational age Neonate), evaluating the effect of the Growth Assessment Protocol (GAP): study protocol for a randomised controlled trial

Author

Vieira, MC, Relph, S, Copas, A, Healey, A, Coxon, K, Alagna, A, Briley, A, Johnson, M, Lawlor, DA, Lees, C, Marlow, N, McCowan, L, Page, L, Peebles, D, Shennan, A, Thilaganathan, B, Khalil, A, Sandall, J, Pasupathy, D, Brocklehurst, P, Tebbs, S, Doré, C, Seed, P, Delaney, L, Cresswell, J, Petty, S, Ajay, B, Wright, B, O'Donnell, H, Howard, M, Wayman, E, Galea, P, Dhanjal, M, Iaschi, E, Hodge, V, Samarage, H, Chita, S, Napolitano, R, Tsikimi, I, Ghalustians, F, Bakalis, S, Cicero, S, Peregrine, E, Smith, L, Janga, D, Hutt, R, and Chandraharan, E

Subjects
Male, Customised growth centiles, Medicine (miscellaneous), INFANTS, Research & Experimental Medicine, CENTILES, law.invention, Fetal Development, Study Protocol, 0302 clinical medicine, HEIGHT, ULTRASONOGRAPHY, Randomized controlled trial, law, Risk Factors, Multicenter Studies as Topic, Pharmacology (medical), DESiGN Collaborative Group, 030212 general & internal medicine, reproductive and urinary physiology, education.field_of_study, lcsh:R5-920, Small-for-gestational-age foetus, Health services research, WOMEN, Stillbirth, female genital diseases and pregnancy complications, PREGNANCY, Medicine, Research & Experimental, Fetal Weight, OBESITY, Infant, Small for Gestational Age, Female, Risk assessment, lcsh:Medicine (General), Life Sciences & Biomedicine, medicine.medical_specialty, Implementation research, Population, Gestational Age, BIRTH-WEIGHT STANDARDS, 1102 Cardiovascular Medicine And Haematology, Ultrasonography, Prenatal, 03 medical and health sciences, Predictive Value of Tests, General & Internal Medicine, Pragmatic Clinical Trials as Topic, medicine, Humans, education, Health economics, Science & Technology, business.industry, Infant, Newborn, Reproducibility of Results, 1103 Clinical Sciences, medicine.disease, United Kingdom, Cardiovascular System & Hematology, Emergency medicine, Small for gestational age, FETAL-GROWTH, Observational study, business, 030217 neurology & neurosurgery
Abstract

Background Stillbirth rates in the United Kingdom (UK) are amongst the highest of all developed nations. The association between small-for-gestational-age (SGA) foetuses and stillbirth is well established, and observational studies suggest that improved antenatal detection of SGA babies may halve the stillbirth rate. The Growth Assessment Protocol (GAP) describes a complex intervention that includes risk assessment for SGA and screening using customised fundal-height growth charts. Increased detection of SGA from the use of GAP has been implicated in the reduction of stillbirth rates by 22%, in observational studies of UK regions where GAP uptake was high. This study will be the first randomised controlled trial examining the clinical efficacy, health economics and implementation of the GAP programme in the antenatal detection of SGA. Methods/design In this randomised controlled trial, clusters comprising a maternity unit (or National Health Service Trust) were randomised to either implementation of the GAP programme, or standard care. The primary outcome is the rate of antenatal ultrasound detection of SGA in infants found to be SGA at birth by both population and customised standards, as this is recognised as being the group with highest risk for perinatal morbidity and mortality. Secondary outcomes include antenatal detection of SGA by population centiles, antenatal detection of SGA by customised centiles, short-term maternal and neonatal outcomes, resource use and economic consequences, and a process evaluation of GAP implementation. Qualitative interviews will be performed to assess facilitators and barriers to implementation of GAP. Discussion This study will be the first to provide data and outcomes from a randomised controlled trial investigating the potential difference between the GAP programme compared to standard care for antenatal ultrasound detection of SGA infants. Accurate information on the performance and service provision requirements of the GAP protocol has the potential to inform national policy decisions on methods to reduce the rate of stillbirth. Trial registration Primary registry and trial identifying number: ISRCTN 67698474. Registered on 2 November 2016. Electronic supplementary material The online version of this article (10.1186/s13063-019-3242-6) contains supplementary material, which is available to authorized users.

Published
2019
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29. Late pregnancy sleep disruption - pathological or physiological?

Author

Cronin, R., primary, Li, M., additional, Thompson, J., additional, Gordon, A., additional, Greenow, C. Raynes, additional, Heazell, A., additional, Stacey, T., additional, Culling, V., additional, Anderson, N., additional, Wilson, J., additional, O'Brien, L., additional, Mitchell, E., additional, Askie, L., additional, and McCowan, L., additional

Published
2019
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30. Paternal contributions to large-for-gestational-age term babies : findings from a multicenter prospective cohort study

Author

Derraik, Jose G. B., Pasupathy, D., McCowan, L. M. E., Poston, L., Taylor, R. S., Simpson, N. A. B., Dekker, G. A., Myers, J., Vieira, M. C., Cutfield, W. S., Ahlsson, Fredrik, Derraik, Jose G. B., Pasupathy, D., McCowan, L. M. E., Poston, L., Taylor, R. S., Simpson, N. A. B., Dekker, G. A., Myers, J., Vieira, M. C., Cutfield, W. S., and Ahlsson, Fredrik

Abstract

We assessed whether paternal demographic, anthropometric and clinical factors influence the risk of an infant being born large-for-gestational-age (LGA). We examined the data on 3659 fathers of term offspring (including 662 LGA infants) born to primiparous women from Screening for Pregnancy Endpoints (SCOPE). LGA was defined as birth weight >90th centile as per INTERGROWTH 21st standards, with reference group being infants <= 90th centile. Associations between paternal factors and likelihood of an LGA infant were examined using univariable and multivariable models. Men who fathered LGA babies were 180 g heavier at birth (P<0.001) and were more likely to have been born macrosomic (P<0.001) than those whose infants were not LGA. Fathers of LGA infants were 2.1 cm taller (P<0.001), 2.8 kg heavier (P<0.001) and had similar body mass index (BMI). In multivariable models, increasing paternal birth weight and height were independently associated with greater odds of having an LGA infant, irrespective of maternal factors. One unit increase in paternal BMI was associated with 2.9% greater odds of having an LGA boy but not girl; however, this association disappeared after adjustment for maternal BMI. There were no associations between paternal demographic factors or clinical history and infant LGA. In conclusion, fathers who were heavier at birth and were taller were more likely to have an LGA infant, but maternal BMI had a dominant influence on LGA.

Published
2019
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31. 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

32. Exercise to support indigenous pregnant women to stop smoking: Acceptability 1 to Māori

Author

Roberts, V, Glover, M, McCowan, L, Walker, N, Ussher, MH, Heke, I, and Maddison, R

Abstract

Objectives\ud Smoking during pregnancy is harmful for the woman and the unborn child, and the harms raise risksfor the child going forward. Indigenous women often have higher rates of smoking prevalence than non-indigenous. Exercise has been proposed as a strategy to help pregnant smokers to quit. Māori (New Zealand Indigenous) women have high rates of physical activity suggesting that an exercise programme to aid quitting could be an attractive initiative. This study explored attitudes towards an exercise programme to aid smoking cessation for Māori pregnant women. \ud \ud Methods\ud Focus groups with Māori pregnant women, and key stakeholder interviews were conducted.\ud \ud Results\ud Overall, participants were supportive of the idea of a physical activity programme for pregnant Māori smokers to aid smoking cessation. The principal, over-arching finding, consistent across all participants, was the critical need for a Kaupapa Māori approach (designed and run by Māori, for \ud Māori people) for successful programme delivery, whereby Māori cultural values are respected and infused throughout all aspects of the programme. A number of practical and environmental barriers to attendance were raised including: cost, the timing of the programme, accessibility, transport, and childcare considerations.\ud \ud Conclusions\ud A feasibility study is needed to design an intervention following the suggestions presented in this paper with effort given to minimising the negative impact of barriers to attendance.

Published
2017

38. STRIDER NZAus: a multicentre randomised controlled trial of sildenafil therapy in early-onset fetal growth restriction.

Author

Groom, KM, McCowan, LM, Mackay, LK, Lee, AC, Gardener, G, Unterscheider, J, Sekar, R, Dickinson, JE, Muller, P, Reid, RA, Watson, D, Welsh, A, Marlow, J, Walker, SP, Hyett, J, Morris, J, Stone, PR, Baker, PN, Groom, K M, and McCowan, L M

Abstract

Objective: To assess the effect of maternal sildenafil therapy on fetal growth in pregnancies with early-onset fetal growth restriction.Design: A randomised placebo-controlled trial.Setting: Thirteen maternal-fetal medicine units across New Zealand and Australia.Population: Women with singleton pregnancies affected by fetal growth restriction at 22+0 to 29+6 weeks.Methods: Women were randomised to oral administration of 25 mg sildenafil citrate or visually matching placebo three times daily until 32+0 weeks, birth or fetal death (whichever occurred first).Main Outcome Measures: The primary outcome was the proportion of pregnancies with an increase in fetal growth velocity. Secondary outcomes included live birth, survival to hospital discharge free of major neonatal morbidity and pre-eclampsia.Results: Sildenafil did not affect the proportion of pregnancies with an increase in fetal growth velocity; 32/61 (52.5%) sildenafil-treated, 39/57 (68.4%) placebo-treated [adjusted odds ratio (OR) 0.49, 95% CI 0.23-1.05] and had no effect on abdominal circumference Z-scores (P = 0.61). Sildenafil use was associated with a lower mean uterine artery pulsatility index after 48 hours of treatment (1.56 versus 1.81; P = 0.02). The live birth rate was 56/63 (88.9%) for sildenafil-treated and 47/59 (79.7%) for placebo-treated (adjusted OR 2.50, 95% CI 0.80-7.79); survival to hospital discharge free of major neonatal morbidity was 42/63 (66.7%) for sildenafil-treated and 33/59 (55.9%) for placebo-treated (adjusted OR 1.93, 95% CI 0.84-4.45); and new-onset pre-eclampsia was 9/51 (17.7%) for sildenafil-treated and 14/55 (25.5%) for placebo-treated (OR 0.67, 95% CI 0.26-1.75).Conclusions: Maternal sildenafil use had no effect on fetal growth velocity. Prospectively planned meta-analyses will determine whether sildenafil exerts other effects on maternal and fetal/neonatal wellbeing.Tweetable Abstract: Maternal sildenafil use has no beneficial effect on growth in early-onset FGR, but also no evidence of harm. [ABSTRACT FROM AUTHOR]

Published
2019
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39. Metabolic syndrome and time to pregnancy: a retrospective study of nulliparous women.

Author

Grieger, JA, Grzeskowiak, LE, Smithers, LG, Bianco‐Miotto, T, Leemaqz, SY, Andraweera, P, Poston, L, McCowan, LM, Kenny, LC, Myers, J, Walker, JJ, Norman, RJ, Dekker, GA, Roberts, CT, Grieger, J A, Grzeskowiak, L E, Smithers, L G, Bianco-Miotto, T, Leemaqz, S Y, and McCowan, L M

Subjects
METABOLIC syndrome, INFERTILITY, PREGNANCY, PREGNANT women, BODY mass index, LOGNORMAL distribution, COMPARATIVE studies, FERTILITY, RESEARCH methodology, MEDICAL cooperation, QUESTIONNAIRES, RESEARCH, RESEARCH funding, EVALUATION research, RETROSPECTIVE studies, PARITY (Obstetrics)
Abstract

Objective: To determine: (1) the association between metabolic syndrome (MetS), time to pregnancy (TTP), and infertility; (2) associations between individual and an increasing number of MetS components, TTP, and infertility; and (3) whether these relationships differ by body mass index (BMI < 30 kg/m2 versus BMI ≥ 30 kg/m2 ).Design: Retrospective cohort study.Setting: Multiple centres (in Australia, Ireland, New Zealand, and the UK).Population: Five thousand five hundred and nineteen low-risk nulliparous pregnant women.Methods: Data on retrospectively reported TTP (number of months to conceive) and a blood sample to assess metabolic health were collected between 14 and 16 weeks of gestation. MetS was defined according to the International Diabetes Federation criteria. Accelerated failure time models with log-normal distribution were conducted to estimate time ratios (TRs) and 95% CIs. Differences in MetS on infertility (TTP > 12 months) were compared using a generalised linear model (Poisson distribution) with robust variance estimates (relative risks, RRs; 95% CIs). All analyses (entire cohort and split by BMI) were controlled for a range of maternal and paternal confounding factors.Main Outcome Measures: Time to pregnancy and infertility.Results: Of the 5519 women included, 12.4% (n = 684) had MetS. Compared with women without MetS, women with MetS had a longer TTP (adjusted TR 1.30; 95% CI 1.15-1.46), which was similar in women who were obese and in women who were not obese. Marginal estimates for median TTP in women with MetS versus without MetS was 3.1 months (3.0-3.3 months) versus 4.1 months (3.6-4.5 months), respectively. Women with MetS were at a 62% greater risk for infertility and were at a greater risk for infertility whether they were obese (adjusted RR 1.62; 95% CI 1.15-2.29) or not (adjusted RR 1.73; 95% CI 1.33-2.23). Reduced high-density lipoprotein cholesterol (HDL-C) and raised triglycerides (TGs) were the main individual components associated with risk for infertility.Conclusion: Metabolic syndrome is associated with longer TTP and infertility, independent of obesity. Additional studies, before pregnancy, are required to support our findings and to determine the applicability of which combinations of metabolic abnormalities pose the greatest risk to delayed fertility, or whether individual components are amenable to modification.Tweetable Abstract: Metabolic syndrome is associated with longer time to pregnancy and infertility, independent of obesity. [ABSTRACT FROM AUTHOR]

Published
2019
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41. Stillbirths: Recall to action in high-income countries.

Author

Goldenberg R.L., Sadler L., Petersen S., Froen J.F., Sisassakos D., Kinney M.V., de Bernis L., Heazell A., Ruidiaz J., Carvalho A., Dahlstrom J., Fox J.P., Gibbons K., Ibiebele I., Kildea S., Gardener G., Lourie R., Wilson P., Gordon A., Kent A., McDonald S., Merchant K., Oats J., Walker S.P., Raven L., Schirmann A., de Montigny F., Guyon G., Blondel B., de Wall S., Bonham S., Corcoran P., Cregan M., Meaney S., Murphy M., Fukui S., Gordijn S., Korteweg F., Cronin R., Masson V., Culling V., Usynina A., Pettersson K., Radestad I., van Gogh S., Bichara B., Bradley S., Ellis A., Downe S., Draper E., Manktelow B., Scott J., Smith L., Stones W., Lavender T., Cacciatore J., Duke W., Fretts R.C., Gold K.J., McClure E., Reddy U., East C., Jennings B., Flenady V., Wojcieszek A.M., Middleton P., Ellwood D., Erwich J.J., Coory M., Khong T.Y., Silver R.M., Smith G.C.S., Boyle F.M., Lawn J.E., Blencowe H., Hopkins Leisher S., Gross M.M., Horey D., Farrales L., Bloomfield F., McCowan L., Brown S.J., Joseph K.S., Zeitlin J., Reinebrant H.E., Ravaldi C., Vannacci A., Cassidy J., Cassidy P., Farquhar C., Wallace E., Siassakos D., Heazell A.E.P., Storey C., Goldenberg R.L., Sadler L., Petersen S., Froen J.F., Sisassakos D., Kinney M.V., de Bernis L., Heazell A., Ruidiaz J., Carvalho A., Dahlstrom J., Fox J.P., Gibbons K., Ibiebele I., Kildea S., Gardener G., Lourie R., Wilson P., Gordon A., Kent A., McDonald S., Merchant K., Oats J., Walker S.P., Raven L., Schirmann A., de Montigny F., Guyon G., Blondel B., de Wall S., Bonham S., Corcoran P., Cregan M., Meaney S., Murphy M., Fukui S., Gordijn S., Korteweg F., Cronin R., Masson V., Culling V., Usynina A., Pettersson K., Radestad I., van Gogh S., Bichara B., Bradley S., Ellis A., Downe S., Draper E., Manktelow B., Scott J., Smith L., Stones W., Lavender T., Cacciatore J., Duke W., Fretts R.C., Gold K.J., McClure E., Reddy U., East C., Jennings B., Flenady V., Wojcieszek A.M., Middleton P., Ellwood D., Erwich J.J., Coory M., Khong T.Y., Silver R.M., Smith G.C.S., Boyle F.M., Lawn J.E., Blencowe H., Hopkins Leisher S., Gross M.M., Horey D., Farrales L., Bloomfield F., McCowan L., Brown S.J., Joseph K.S., Zeitlin J., Reinebrant H.E., Ravaldi C., Vannacci A., Cassidy J., Cassidy P., Farquhar C., Wallace E., Siassakos D., Heazell A.E.P., and Storey C.

Abstract

Summary Variation in stillbirth rates across high-income countries and large equity gaps within high-income countries persist. If all high-income countries achieved stillbirth rates equal to the best performing countries, 19 439 late gestation (28 weeks or more) stillbirths could have been avoided in 2015. The proportion of unexplained stillbirths is high and can be addressed through improvements in data collection, investigation, and classification, and with a better understanding of causal pathways. Substandard care contributes to 20-30% of all stillbirths and the contribution is even higher for late gestation intrapartum stillbirths. National perinatal mortality audit programmes need to be implemented in all high-income countries. The need to reduce stigma and fatalism related to stillbirth and to improve bereavement care are also clear, persisting priorities for action. In high-income countries, a woman living under adverse socioeconomic circumstances has twice the risk of having a stillborn child when compared to her more advantaged counterparts. Programmes at community and country level need to improve health in disadvantaged families to address these inequities.Copyright © 2016 Elsevier Ltd.

Published
2016

42. Nifedipine maintenance tocolysis and perinatal outcome : an individual participant data meta-analysis

Author

van Vliet, E. O. G., Dijkema, G. H., Schuit, E., Heida, K. Y., Roos, C., van der Post, J. A. M., Parry, E. C., McCowan, L., Lyell, D. J., El-Sayed, Y. Y., Carr, D. B., Clark, A. L., Mahdy, Z. A., Uma, M., Sayin, N. C., Varol, G. F., Mol, B. W., Oudijk, M. A., van Vliet, E. O. G., Dijkema, G. H., Schuit, E., Heida, K. Y., Roos, C., van der Post, J. A. M., Parry, E. C., McCowan, L., Lyell, D. J., El-Sayed, Y. Y., Carr, D. B., Clark, A. L., Mahdy, Z. A., Uma, M., Sayin, N. C., Varol, G. F., Mol, B. W., and Oudijk, M. A.

Published
2016

43. Nifedipine maintenance tocolysis and perinatal outcome: an individual participant data meta-analysis

Author

MS Verloskunde, Epi Methoden Team 1, Epi Methoden Team 4, Arts-assistenten DV&B, Brain, Other research (not in main researchprogram), van Vliet, E. O. G., Dijkema, G. H., Schuit, E., Heida, K. Y., Roos, C., van der Post, J. A. M., Parry, E. C., McCowan, L., Lyell, D. J., El-Sayed, Y. Y., Carr, D. B., Clark, A. L., Mahdy, Z. A., Uma, M., Sayin, N. C., Varol, G. F., Mol, B. W., Oudijk, M. A., MS Verloskunde, Epi Methoden Team 1, Epi Methoden Team 4, Arts-assistenten DV&B, Brain, Other research (not in main researchprogram), van Vliet, E. O. G., Dijkema, G. H., Schuit, E., Heida, K. Y., Roos, C., van der Post, J. A. M., Parry, E. C., McCowan, L., Lyell, D. J., El-Sayed, Y. Y., Carr, D. B., Clark, A. L., Mahdy, Z. A., Uma, M., Sayin, N. C., Varol, G. F., Mol, B. W., and Oudijk, M. A.

Published
2016

44. Nifedipine maintenance tocolysis and perinatal outcome: an individual participant data meta-analysis

Author

van Vliet, EOG, primary, Dijkema, GH, additional, Schuit, E, additional, Heida, KY, additional, Roos, C, additional, van der Post, JAM, additional, Parry, EC, additional, McCowan, L, additional, Lyell, DJ, additional, El-Sayed, YY, additional, Carr, DB, additional, Clark, AL, additional, Mahdy, ZA, additional, Uma, M, additional, Sayin, NC, additional, Varol, GF, additional, Mol, BW, additional, and Oudijk, MA, additional

Published
2016
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46. The AMI Meeting Corpus: A Pre-Announcement

Author

Carletta, J., Ashby, S., Bourban, S., Flynn, M., Guillemot, M., Hain, T., Kadlec, J., Karaiskos, V., Kraaij, W., Kronenthal, M., Lathoud, G., Lincoln, M., Lisowska, A., McCowan, L., Post, W., Reidsma, D., Wellner, P., Corporatie AMI Project Consortium, ISBN 9783540325499, ISSN 03029743, Reeks, and TNO Defensie en Veiligheid

Subjects
Orthographic transcription, Informatics, Learning systems, Data acquisition, AMI Meeting, Information technology, Multi-modal data set, Recordings, Project management, Technical presentations, Set theory, Microphones, Web browsers, Multi agent systems, Video cameras
Abstract

The AMI Meeting Corpus is a multi-modal data set consisting of 100 hours of meeting recordings. It is being created in the context of a project that is developing meeting browsing technology and will eventually be released publicly. Some of the meetings it contains are naturally occurring, and some are elicited, particularly using a scenario in which the participants play different roles in a design team, taking a design project from kick-o' to completion over the course of a day. The corpus is being recorded using a wide range of devices including close-talking and far-field microphones, individual and room-view video cameras, projection, a whiteboard, and individual pens, all of which produce output signals that are synchronized with each other. It is also being hand-annotated for many different phenomena, including orthographic transcription, discourse properties such as named entities and dialogue acts, summaries, emotions, and some head and hand gestures. We describe the data set, including the rationale behind using elicited material, and explain how the material is being recorded, transcribed and annotated.

Published
2006

47. Association between maternal sleep practices and late stillbirth - findings from a stillbirth case-control study.

Author

Heazell, A. E. P., Li, M., Budd, J., Thompson, J. M. D., Stacey, T., Cronin, R. S., Martin, B., Roberts, D., Mitchell, E. A., McCowan, L. M. E., Heazell, Aep, Thompson, Jmd, and McCowan, Lme

Subjects
STILLBIRTH, HEALTH, SLEEP, BODY mass index, FETAL death, HUMAN abnormalities, GESTATIONAL age, HOSPITAL wards, INTERVIEWING, LONGITUDINAL method, MATERNAL health services, NATIONAL health services, PERINATAL death, THIRD trimester of pregnancy, SUPINE position, CASE-control method
Abstract

Objective: To report maternal sleep practices in women who experienced a stillbirth compared with controls with ongoing live pregnancies at similar gestation.Design: Prospective case-control study.Setting: Forty-one maternity units in the United Kingdom.Population: Women who had a stillbirth after ≥ 28 weeks' gestation (n = 291) and women with an ongoing pregnancy at the time of interview (n = 733).Methods: Data were collected using an interviewer-administered questionnaire that included questions on maternal sleep practices before pregnancy, in the four weeks prior to, and on the night before the interview/stillbirth.Main Outcome Measures: Maternal sleep practices during pregnancy.Results: In multivariable analysis, supine going-to-sleep position the night before stillbirth had a 2.3-fold increased risk of late stillbirth [adjusted Odds Ratio (aOR) 2.31, 95% CI 1.04-5.11] compared with the left side. In addition, women who had a stillbirth were more likely to report sleep duration less than 5.5 hours on the night before stillbirth (aOR 1.83, 95% CI 1.24-2.68), getting up to the toilet once or less (aOR 2.81, 95% CI 1.85-4.26), and a daytime nap every day (aOR 2.22, 95% CI 1.26-3.94). No interaction was detected between supine going-to-sleep position and a small-for-gestational-age infant, maternal body mass index, or gestational age. The population-attributable risk for supine going-to-sleep position was 3.7% (95% CI 0.5-9.2).Conclusions: This study confirms that supine going-to-sleep position is associated with late stillbirth. Further work is required to determine whether intervention(s) can decrease the frequency of supine going-to-sleep position and the incidence of late stillbirth.Tweetable Abstract: Supine going-to-sleep position is associated with 2.3× increased risk of stillbirth after 28 weeks' gestation.Plain Language Summary: Stillbirth, the death of a baby before birth, is a tragedy for mothers and families. One approach to reduce stillbirths is to identify factors that are associated with stillbirth. There are few risk factors for stillbirth that can be easily changed, but this study is looking at identifying how mothers may be able to reduce their risk. In this study, we interviewed 291 women who had a stillbirth and 733 women who had a live-born baby from 41 maternity units throughout the UK. The mothers who had a stillbirth were interviewed as soon as practical after their baby died. Mothers who had a live birth were interviewed during their pregnancies at the same times in pregnancy as when the stillbirths occurred. We did not interview mothers who had twins or who had a baby with a major abnormality. Mothers who went to sleep on their back had at least twice the risk of stillbirth compared with mothers who went to sleep on their left-hand side. This study suggests that 3.7% of stillbirths after 28 weeks of pregnancy were linked with going to sleep lying on the back. This study also shows that the link between going-to-sleep position and late stillbirth was not affected by the duration of pregnancy after 28 weeks, the size of the baby, or the mother's weight. Women who got up to the toilet once or more at night had a reduced risk of stillbirth. This is the largest of four similar studies that have all shown the same link between the position in which a mother goes to sleep and stillbirth after 28 weeks of pregnancy. Further studies are needed to see whether women can easily change their sleep position in late pregnancy and whether changing the position a mother goes to sleep in reduces stillbirth. [ABSTRACT FROM AUTHOR]

Published
2018
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48. The NIFTY study: A multicentre randomised double-blind placebo-controlled trial of nifedipine maintenance tocolysis in fetal fibronectin-positive women in threatened preterm labour

Author

Parry, E., Roos, C., Stone, P., Hayward, L., Mol, B.W., McCowan, L., Parry, E., Roos, C., Stone, P., Hayward, L., Mol, B.W., and McCowan, L.

Abstract

Item does not contain fulltext, OBJECTIVE: In an unselected group of women with signs of preterm labour, maintenance tocolysis is not effective in the prevention of preterm birth and does not improve neonatal outcome. Among women with signs of preterm labour, those who are fetal fibronectin positive have an increased risk of preterm birth. We investigated whether maintenance tocolysis with nifedipine would delay delivery and improve neonatal outcome in women with threatened preterm labour and a positive fetal fibronectin status. STUDY DESIGN: Women with a singleton pregnancy in threatened preterm labour (24(+0) to 33(+6) weeks) with a positive fetal fibronectin test were randomised to nifedipine or placebo. Study medication was continued until 36 completed weeks' gestation. The primary endpoint was prolongation of pregnancy of seven days. Secondary endpoints were gestational age at delivery and length of NICU admission. RESULTS: Of the 60 participants, 29 received nifedipine and 31 placebo. Prolongation of pregnancy by >7 days occurred in 22/29 (76%) in the nifedipine group and 25/31 (81%) in the placebo group (relative risks, RR 0.94 [0.72-1.2]). Gestational age at delivery was 36.1 +/- 5.1 weeks for nifedipine and 36.8 +/- 3.6 weeks for placebo (P = 0.027). Length of NICU admission [median (interquartile ranges, IQR)] was 27 (24-41) days and 16 (8-37) days in nifedipine and placebo groups, respectively (P = 0.17). CONCLUSION: In women with threatened preterm labour who are fetal fibronectin positive, maintenance tocolysis with nifedipine does not seem to prolong pregnancy, nor reduce length of NICU admission.

Published
2014

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