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1. Metformin in pregnancy and childhood neurodevelopmental outcomes: a systematic review and meta-analysis

Author

Gordon, HG, Atkinson, JA, Tong, S, Mehdipour, P, Cluver, C, Walker, SP, Lindquist, AC, Hastie, RM, Gordon, HG, Atkinson, JA, Tong, S, Mehdipour, P, Cluver, C, Walker, SP, Lindquist, AC, and Hastie, RM

Abstract

OBJECTIVE: This study aimed to examine the impact of maternal metformin use during pregnancy on offspring neurodevelopmental outcomes. DATA SOURCES: MEDLINE, Embase, and Web of Science (Core Collection) were searched from inception until July 1, 2023. STUDY ELIGIBILITY CRITERIA: Studies of women who received treatment with metformin at any stage of pregnancy for any indication with neurodevelopmental data available for their offspring were included. Studies without a control group were excluded. Randomized controlled trials, case-control, cohort, and cross-sectional studies were included in the review. METHODS: Studies were screened for inclusion and data were extracted independently by 2 reviewers. Risk of bias was assessed using a modified version of the Newcastle-Ottawa Scale for nonrandomized studies, and the Risk of Bias 2 tool for randomized trials. RESULTS: A total of 7 studies met the inclusion criteria, including a combined cohort of 14,042 children with 7641 children who were exposed and followed for up to 14 years of age. Metformin use during pregnancy was not associated with neurodevelopmental delay in infancy (relative risk, 1.09; 95% confidence interval, 0.54-2.17; 3 studies; 9668 children) or at ages 3 to 5 years (relative risk, 0.90; 95% confidence interval, 0.56-1.45; 2 studies; 6118 children). When compared with unexposed peers, metformin use during pregnancy was not associated with altered motor scores (mean difference, 0.30; 95% confidence interval, -1.15 to 1.74; 3 studies; 714 children) or cognitive scores (mean difference, -0.45; 95% confidence interval, -1.45 to 0.55; 4 studies; 734 children). Studies that were included were of high quality and deemed to be at low risk of bias. CONCLUSION: In utero exposure to metformin does not seem to be associated with adverse neurodevelopmental outcomes in children up to the age of 14 years. These findings provide reassurance to clinicians and pregnant women considering metformin use during pregnancy.

Published
2024

4. The need for appropriate language in the debate on medicalisation of pregnancy

Author

Cluver, C, de Groot, C, Mol, BW, Murphy, KE, Norman, JE, Pacagnella, R, Palmer, K, Poon, LC, Rolnik, DL, Spong, CY, Stock, SJ, Thangaratinam, S, Tong, S, Verhoeven, C, Vuong, LN, Walker, SP, Xiaohua, L, Cluver, C, de Groot, C, Mol, BW, Murphy, KE, Norman, JE, Pacagnella, R, Palmer, K, Poon, LC, Rolnik, DL, Spong, CY, Stock, SJ, Thangaratinam, S, Tong, S, Verhoeven, C, Vuong, LN, Walker, SP, and Xiaohua, L

Published
2023

5. An LC-MS/MS method for the simultaneous quantitation of sulfasalazine and sulfapyridine in human placenta.

Author

Louw, V, Brownfoot, F, Cluver, C, Decloedt, E, Kellermann, T, Louw, V, Brownfoot, F, Cluver, C, Decloedt, E, and Kellermann, T

Abstract

Sulfasalazine has been identified as a candidate molecule to be investigated as an intervention to treat preterm pre-eclampsia during pregnancy. However, placental exposure of sulfasalazine and its systemically absorbed metabolite, sulfapyridine, is unknown. A robust liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed and validated to simultaneously quantitate these analytes in human placenta with an application to a pilot clinical trial. The placental tissue was homogenised using a water:methanol (1:1, v/v) mixture, followed by sample extraction using both protein precipitation and solid phase extraction. Sulfasalazine-d4 and sulfapyridine-d4 were used as internal standards. An Agilent Poroshell EC-C18 (3.0 ×100 mm, 2.7 µm) column was used for chromatographic separation, with gradient elution employed at a flow rate of 0.450 mL/min over a total run time of seven minutes. The mobile phases consisted of water with 0.1% formic acid (mobile phase A) and acetonitrile:methanol (90:10, v/v) with 0.1% formic acid (mobile phase B). A Shimadzu-8040 mass spectrometer was operated in multiple reaction monitoring (MRM) mode using positive electrospray ionisation (ESI). For both analytes, the assay was validated over the range 30-30,000 ng/mL, or 150-150,000 ng/g. During inter-day validations (n = 18), the average accuracies of quality controls ranged from 101.6% to 112.7% with corresponding precisions of 4.4-6.7% for sulfasalazine, and from 97.4% to 108.4%, with corresponding precisions of 3.7-10.0% for sulfapyridine. No significant matrix effects were observed, and the method proved to be sensitive and specific for both analytes. This study presents the first validated analytical method for quantifying sulfasalazine and sulfapyridine in human placenta as part of a pilot clinical trial to generate preliminary data on its pharmacokinetics and efficacy as in intervention for preterm pre-eclampsia.

Published
2023

7. Standardising definitions for the pre-eclampsia core outcome set: A consensus development study

Author

Duffy, J. M. N., Cairns, A. E., Magee, L. A., von Dadelszen, P., van 't Hooft, J., Gale, C., Brown, M., Chappell, L. C., Grobman, W. A., Fitzpatrick, R., Karumanchi, S. A., Lucas, D. N., Mol, B., Stark, M., Thangaratinam, S., Wilson, M. J., Williamson, P. R., Ziebland, S., Mcmanus, R. J., Abalos, E. J., Adamson, C. C. D., Akadri, A. A., Akturk, Z., Allegaert, K., Angel-Muller, E., Antretter, J., Ashdown, H. F., Audibert, F., Auger, N., Aygun, C., Babic, I., Bagga, R., Baker, J. M., Beebeejaun, Y., Bhakta, P., Bhandari, V., Bhattacharya, S., Blanker, M. H., Bloomfield, F. H., Bof, A., Brennan, S. M., Broekhuijsen, K., Broughton Pipkin, F., Browne, J. L., Browning, R. M., Bull, J. W., Butt, A., Button, D., Campbell, J. P., Campbell, D. M., Carbillon, L., Carthy, S., Casely, E., Cave, J. A., Cecatti, J. G., Chamillard, M. E., Chassard, D., Checheir, N. C., Chulkov, V. S., Cluver, C. A., Crawford, C. F., Daly, M. C., Darmochwal-Kolarz, D. A., Davies, R. E., Davies, M. W., Dawson, J. S., Dobson, N., Dodd, C. N., Donald, F., Duley, L., Epstein-Mares, J., Erez, O., Evans, E., Farlie, R. N., Ferris, A. V., Frankland, E. M., Freeman, D. J., Gainder, S., Ganzevoort, W., Gbinigie, O. A., Gerval, M. -O., Ghosh, S. K., Gingel, L. J., Glogowska, M., Goodlife, A., Gough, K. L., Green, J. R., Gul, F., Haggerty, L., Hall, D. R., Hallman, M., Hamilton, L. M., Hammond, S. J., Harlow, S. D., Hays, K. E., Hickey, S. C., Higgins, M., Hinton, L., Hobson, S. R., Hogg, M. J., Hollands, H. J., Homer, C. S. E., Hoodbhoy, Z., Howell, P., Huppertz, B., Husain, S., Jacoby, S. D., Jacqz-Aigrain, E., Jenkins, G., Jewel, D., Johnson, M. J., Johnston, C. L., Jones, P. M., Kantrowitz-Gordon, I., Khan, R. -U., Kirby, L. J., Kirk, C., Knight, M., Korey, M. T., Lee, G. J., Lee, V. W., Levene, L. S., Londero, A. P., Lust, K. M., Mackenzie, V., Malha, L., Mattone, M., Mccartney, D. E., Mcfadden, A., Mckinstry, B. H., Middleton, P. F., Mills, D. J., Mistry, H. D., Mitchell, C. A., Mockler, J. C., Molsher, S. -A., Monast, E. S., Moodley, J., Mooij, R., Moore, E. L., Morgan, L., Moulson, A., Mughal, F., Mundle, S. R., Munoz, M. A., Murray, E., Nagata, C., Nair, A. S., Nakimuli, A., Nath, G., Newport, R. S., Oakeshott, P., Ochoa-Ferraro, M. R., Odendaal, H., Ohkuchi, A., Oliveira, L., Ortiz-Panozo, E., Oudijk, M. A., Oygucu, S. E., Paech, M. J., Painter, R. C., Parry, C. L., Payne, B. A., Pearson, E. L., Phupong, V., Pickett, N., Pickles, K. A., Plumb, L. K., Prefumo, F., Preston, R., Ray, J. G., Rayment, J., Regan, L. V., Rey, E., Robson, E. J., Rubin, A. N., Rubio-Romero, J. A., Rull, K., Sass, N., Sauve, N., Savory, N. A., Scott, J. R., Seaton, S. E., Seed, P. T., Shakespeare, J. M., Shand, A. W., Sharma, S., Shaw, T. Y., Smedley, K. L., Smith, D., Smith Conk, A., Soward, D., Stepan, H., Stroumpoulis, K., Surendran, A., Takeda, S., Tan, L., Theriot, B. S., Thomas, H. F., Thompson, K., Thompson, P. I., Thompson, M. J., Toms, L., Torney, K. L. H. T., Treadwell, J. S., Tucker, K. L., Turrentine, M. A., Van Hecke, O., Van Oostwaard, M. F., Vasquez, D. N., Vaughan, D. J. A., Vinturache, A., Walker, J., Wardle, S. P., Wasim, T., Waters, J. H., Whitehead, C. L., Wolfson, A., Yeo, S., Zermansky, A. G., (iHOPE), International Collaboration to Harmonise Outcomes for Pre-eclampsia, Life Course Epidemiology (LCE), University of Oxford, University College London, King’s College London, Academic Medical Center, Imperial College London, St George Hospital and University of New South Wales, Northwestern University, Cedars-Sinai Medical Center, London North West University Healthcare NHS Trust, Monash University, University of Adelaide, Barts and The London School of Medicine and Dentistry, University of Sheffield, University of Liverpool, Centro Rosarino de Estudios Perinatales, Chelsea and Westminster Hospital NHS Foundation Trust, Babcock University, Ailem Academic Counselling, KU Leuven, Universidad Nacional de Colombia, Northwell Health, Université de Montréal, University of Montreal Hospital Centre, Ondokuz Mayıs University, Prince Sultan Military Medical City, Postgraduate Institute of Medical Education and Research, Fetal Medicine Research Institute, University Hospital Limerick, Drexel University, University of Aberdeen, University of Groningen, University of Auckland, Haaglanden Medisch Centrum, Nottingham University Medical School, Utrecht University, King Edward Memorial Hospital for Women, Imperial College Healthcare NHS Trust, Jean-Verdier Hospital, Downland Practice, Universidade Estadual de Campinas (UNICAMP), Université Lyon, University of North Carolina School of Medicine, South Ural State Medical University, Stellenbosch University, Irish Neonatal Health Alliance, University of Rzeszow, Royal Brisbane and Women’s Hospital, Nottingham University Hospitals NHS Trust, University Hospitals of Leicester, North Bristol NHS Trust, University of Nottingham, Soroka University Medical Center Ben Gurion University of the Negev, St George’s University Hospitals NHS Foundation Trust, Hospitalsenhed Midt, University of Glasgow, Amsterdam Universitair Medische Centra, All India Institute of Medical Sciences Patna, Luton and Dunstable University Hospital, Khyber Medical University Institution of Medical Sciences, Midwife Mid Essex Hospitals NHS Trust, University of Oulu, University of Michigan, Bastyr University, Irish Nurses and Midwives Organisation, University of Toronto, Barts Health NHS Trust, University Hospitals Plymouth NHS Trust, Burnet Institute, Aga Khan University, Medical University of Graz, Homerton University Hospital NHS Foundation Trust, Mount Royal University, Université de Paris, Royal Surrey County Hospital, University Hospital Southampton NHS Foundation Trust, University of Washington School of Nursing, Evelina London Children's Hospital Neonatal Unit, University of Sydney, University of Leicester, Academic Hospital of Udine, NHS Borders, Weill Cornell Medical College, University of Dundee, University of Edinburgh, South Australian Health and Medical Research Institute, Monash University and Monash Health, United Lincolnshire Hospitals NHS Trust, University of Kwa Zulu-Natal, Beatrix Hospital, Keele University, Government Medical College, Institut Catala de la Salut. IdiapJgol, National Center for Child Health and Development, Basavatarakam Indo-American Cancer Hospital and Research Institute, Axon Anaesthesia Associates, Pennine Acute Hospitals NHS Trust, University of London, Norfolk and Norwich University Hospital, Jichi Medical University School of Medicine, Universidade Estadual Paulista (UNESP), National Institute of Public Health, University of Kyrenia, King Edward Memorial Hospital, Amsterdam University Centres, University of British Columbia, Chulalongkorn University, University of Brescia, University Of British Columbia, University of Montreal, Women's Clinic of Tartu University Hospital, Universidade Federal de São Paulo (UNIFESP), Université de Sherbrooke, University Hospital of Wales, University of Iowa, King's College London, Westmead Hospital, Princess Royal Maternity, Leipzig University, Centre Hospitalier Public du Cotentin, Lewisham and Greenwich NHS Trust, Juntendo University Faculty of Medicine, Western Sydney University, National Institute of Health Research, University of Washington, Baylor College of Medicine, Capelle aan den Ijssel, Sanatorio Anchorena, Oxford University Hospitals NHS Foundation Trust, University of Leeds, Institute of Medical Sciences, UPMC Magee Womens Hospital, Penn Medicine Princeton Health, University of North Carolina at Chapel Hill, and Obstetrics and Gynaecology

Subjects
Adult, medicine.medical_specialty, Consensus, Delphi Technique, Standardization, Birth weight, Psychological intervention, Randomised controlled trials, 030204 cardiovascular system & hematology, Outcome (game theory), 03 medical and health sciences, Hypertension in pregnancy, Outcome measure, 0302 clinical medicine, Pre-Eclampsia, Pregnancy, Consensus development study, Internal Medicine, medicine, Humans, Set (psychology), 030219 obstetrics & reproductive medicine, Eclampsia, business.industry, Pregnancy Outcome, Obstetrics and Gynecology, Core outcome set, Reference Standards, medicine.disease, Pre-eclampsia, Pregnancy Complications, Core (game theory), Treatment Outcome, Systematic review, Family medicine, 1114 Paediatrics and Reproductive Medicine, Female, International Collaboration to Harmonise Outcomes for Pre-eclampsia (iHOPE), business
Abstract

Made available in DSpace on 2022-04-28T19:29:02Z (GMT). No. of bitstreams: 0 Previous issue date: 2020-07-01 Medical Research Council Canada National Institute for Health Research Objectives: To develop consensus definitions for the core outcome set for pre-eclampsia. Study design: Potential definitions for individual core outcomes were identified across four formal definition development initiatives, nine national and international guidelines, 12 Cochrane systematic reviews, and 79 randomised trials. Eighty-six definitions were entered into the consensus development meeting. Ten healthcare professionals and three researchers, including six participants who had experience of conducting research in low- and middle-income countries, participated in the consensus development process. The final core outcome set was approved by an international steering group. Results: Consensus definitions were developed for all core outcomes. When considering stroke, pulmonary oedema, acute kidney injury, raised liver enzymes, low platelets, birth weight, and neonatal seizures, consensus definitions were developed specifically for low- and middle-income countries because of the limited availability of diagnostic interventions including computerised tomography, chest x-ray, laboratory tests, equipment, and electroencephalogram monitoring. Conclusions: Consensus on measurements for the pre-eclampsia core outcome set will help to ensure consistency across future randomised trials and systematic reviews. Such standardization should make research evidence more accessible and facilitate the translation of research into clinical practice. Video abstract can be available at: www.dropbox.com/s/ftrgvrfu0u9glqd/6.%20Standardising%20definitions%20in%20teh%20pre-eclampsia%20core%20outcome%20set%3A%20a%20consensus%20development%20study.mp4?dl=0. Nuffield Department of Primary Care Health Sciences University of Oxford Institute for Women’s Health University College London Department of Women and Children’s Health School of Life Course Sciences King’s College London Department of Obstetrics and Gynecology Amsterdam UMC Academic Medical Center Academic Neonatal Medicine Imperial College London Department of Renal Medicine St George Hospital and University of New South Wales Department of Obstetrics and Gynaecology Feinberg School of Medicine Northwestern University Health Services Research Unit Nuffield Department of Population Health University of Oxford Cedars-Sinai Medical Center London North West University Healthcare NHS Trust Women’s Health Care Research Group Department of Obstetrics and Gynaecology Monash University Department of Obstetrics and Gynaecology University of Adelaide Women’s Health Research Unit Barts and The London School of Medicine and Dentistry School of Health and Related Research University of Sheffield MRC North West Hub for Trials Methodology Research Department of Biostatistics University of Liverpool Centro Rosarino de Estudios Perinatales Chelsea and Westminster Hospital NHS Foundation Trust Babcock University Ailem Academic Counselling KU Leuven Universidad Nacional de Colombia Northwell Health University of Oxford Université de Montréal University of Montreal Hospital Centre Ondokuz Mayıs University Prince Sultan Military Medical City Postgraduate Institute of Medical Education and Research King's Fertility Fetal Medicine Research Institute University Hospital Limerick Drexel University University of Aberdeen University of Groningen University of Auckland Haaglanden Medisch Centrum Nottingham University Medical School Utrecht University King Edward Memorial Hospital for Women Imperial College Healthcare NHS Trust Jean-Verdier Hospital Downland Practice University of Campinas Université Lyon University of North Carolina School of Medicine South Ural State Medical University Stellenbosch University Irish Neonatal Health Alliance University of Rzeszow Royal Brisbane and Women’s Hospital Nottingham University Hospitals NHS Trust University Hospitals of Leicester North Bristol NHS Trust University of Nottingham Soroka University Medical Center Ben Gurion University of the Negev St George’s University Hospitals NHS Foundation Trust Hospitalsenhed Midt University of Glasgow Amsterdam Universitair Medische Centra All India Institute of Medical Sciences Patna Luton and Dunstable University Hospital Khyber Medical University Institution of Medical Sciences Midwife Mid Essex Hospitals NHS Trust University of Oulu University of Michigan Bastyr University Irish Nurses and Midwives Organisation University of Toronto Barts Health NHS Trust University Hospitals Plymouth NHS Trust Burnet Institute Aga Khan University Medical University of Graz Homerton University Hospital NHS Foundation Trust Mount Royal University Université de Paris Royal Surrey County Hospital University Hospital Southampton NHS Foundation Trust University of Washington School of Nursing Evelina London Children's Hospital Neonatal Unit University of Sydney University of Leicester Academic Hospital of Udine NHS Borders Weill Cornell Medical College University of Dundee University of Edinburgh South Australian Health and Medical Research Institute University of Sheffield Monash University and Monash Health United Lincolnshire Hospitals NHS Trust University of Kwa Zulu-Natal Beatrix Hospital Keele University Government Medical College Institut Catala de la Salut. IdiapJgol University College London National Center for Child Health and Development Basavatarakam Indo-American Cancer Hospital and Research Institute Axon Anaesthesia Associates Pennine Acute Hospitals NHS Trust St George's University of London Norfolk and Norwich University Hospital Jichi Medical University School of Medicine São Paulo State University National Institute of Public Health University of Kyrenia King Edward Memorial Hospital Amsterdam University Centres University of British Columbia Chulalongkorn University University of Brescia University Of British Columbia University of Montreal Women's Clinic of Tartu University Hospital Universidade Federal de São Paulo Université de Sherbrooke University Hospital of Wales University of Iowa King's College London Westmead Hospital Princess Royal Maternity Leipzig University Centre Hospitalier Public du Cotentin Lewisham and Greenwich NHS Trust Juntendo University Faculty of Medicine Western Sydney University National Institute of Health Research University of Washington Baylor College of Medicine Capelle aan den Ijssel Sanatorio Anchorena Oxford University Hospitals NHS Foundation Trust University of Leeds Institute of Medical Sciences UPMC Magee Womens Hospital Penn Medicine Princeton Health University of North Carolina at Chapel Hill São Paulo State University

Published
2020
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8. Cerebral biomarkers in neurologic complications of preeclampsia

Author

Bergman, L, Hastie, R, Bokstrom-Rees, E, Zetterberg, H, Blennow, K, Schell, S, Imberg, H, Langenegger, E, Moodley, A, Walker, S, Tong, S, Cluver, C, Bergman, L, Hastie, R, Bokstrom-Rees, E, Zetterberg, H, Blennow, K, Schell, S, Imberg, H, Langenegger, E, Moodley, A, Walker, S, Tong, S, and Cluver, C

Abstract

BACKGROUND: There is no tool to accurately predict who is at risk of developing neurologic complications of preeclampsia, and there is no objective method to determine disease severity. OBJECTIVE: We assessed whether plasma concentrations of the cerebral biomarkers neurofilament light, tau, and glial fibrillary acidic protein could reflect disease severity in several phenotypes of preeclampsia. Furthermore, we compared the cerebral biomarkers with the angiogenic biomarkers soluble fms-like tyrosine kinase 1, placental growth factor, and soluble endoglin. STUDY DESIGN: In this observational study, we included women from the South African Preeclampsia Obstetric Adverse Events biobank. Plasma samples taken at diagnosis (preeclampsia cases) or admission for delivery (normotensive controls) were analyzed for concentrations of neurofilament light, tau, glial fibrillary acidic protein, placental growth factor, soluble fms-like tyrosine kinase 1, and soluble endoglin. The cerebrospinal fluid concentrations of inflammatory markers and albumin were analyzed in a subgroup of 15 women. Analyses were adjusted for gestational age, time from seizures and delivery to sampling, maternal age, and parity. RESULTS: Compared with 28 women with normotensive pregnancies, 146 women with preeclampsia demonstrated 2.18-fold higher plasma concentrations of neurofilament light (95% confidence interval, 1.64-2.88), 2.17-fold higher tau (95% confidence interval, 1.49-3.16), and 2.77-fold higher glial fibrillary acidic protein (95% confidence interval, 2.06-3.72). Overall, 72 women with neurologic complications (eclampsia, cortical blindness, and stroke) demonstrated increased plasma concentrations of tau (2.99-fold higher; 95% confidence interval, 1.92-4.65) and glial fibrillary acidic protein (3.22-fold higher; 95% confidence interval, 2.06-5.02) compared with women with preeclampsia without pulmonary edema; hemolysis, elevated liver enzymes, and low platelet count; or neurologic complications

Published
2022

9. Pravastatin, proton-pump inhibitors, metformin, micronutrients, and biologics: new horizons for the prevention or treatment of preeclampsia

Author

Tong, S, Kaitu'u-Lino, TJ, Hastie, R, Brownfoot, F, Cluver, C, Hannan, N, Tong, S, Kaitu'u-Lino, TJ, Hastie, R, Brownfoot, F, Cluver, C, and Hannan, N

Abstract

There has been increasing research momentum to identify new therapeutic agents for the prevention or treatment of preeclampsia, drugs that can affect the underlying disease pathophysiology. Molecular targets of candidate treatments include oxidative stress, antiangiogenic factors, and the angiotensin, nitric oxide, and proinflammatory pathways. The proposed treatments undergoing preclinical and clinical trial evaluation are thought to act on placental or endothelial disease or both. Most have adopted the pragmatic strategy of repurposing drugs. Of all the therapeutic agents proposed, pravastatin has received the most interest. There are preclinical studies showing that it has pleiotropic actions that favorably impact on multiple molecular targets and can resolve a preeclampsia phenotype in many animal models. An early phase clinical trial suggests that it may have therapeutic activity. Several large prevention trials are planned or ongoing and, when completed, could definitively address whether pravastatin can prevent preeclampsia. Proton-pump inhibitors, metformin, and sulfasalazine are other drugs with preclinical evidence of multiple molecular actions that could resolve the pathophysiology of preeclampsia. These agents are also currently being evaluated in clinical trials. There have been many recent preclinical studies identifying the potential of numerous natural compounds to treat preeclampsia, such as plant extracts and micronutrients that have potent anti-inflammatory or antioxidant activity. Recent preclinical studies have also proposed novel molecular-targeted strategies, such as monoclonal antibodies targeting tumor necrosis factor alpha, placental growth factor, and short interfering RNA technology, to silence the gene expression of soluble fms-like tyrosine kinase-1 or angiotensinogen. Other treatment approaches that have transitioned to human trials (ranging from single-arm to phase III trials that have been completed or are ongoing) include folic acid

Published
2022

10. Maternal propranolol treatment for fetal pleural effusion.

Author

Cluver, C. A., Alexander, R., and Pistorius, L.

Subjects
*BETA adrenoceptors, *VASCULAR endothelial growth factors, *CONGENITAL heart disease, *DELIVERY (Obstetrics), *SUPRAVENTRICULAR tachycardia, *POLYHYDRAMNIOS, *HYDROPS fetalis
Abstract

The article discusses the use of maternal propranolol treatment as a potential therapy for fetal pleural effusion, specifically chylothorax. Propranolol, a non-selective beta blocker, has shown promise in treating lymphatic malformations in infants and children. A case study presented in the article describes successful resolution of fetal pleural effusion with maternal propranolol therapy, highlighting the potential benefits of this approach over invasive procedures. Further research is needed to evaluate the efficacy of propranolol in treating fetal chylothorax. [Extracted from the article]

Published
2024
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11. Maternal and neonatal outcomes of COVID-19 in a high-risk pregnant cohort with and without HIV

Author

De Waard, L, primary, Langenegger, E, additional, Erasmus, K, additional, Van der Merwe, T, additional, Olivier, S E, additional, Du Toit, N, additional, Paulsen, C, additional, Nkangana, N, additional, Van Niekerk, M, additional, Moodley, A, additional, Schell, S, additional, Taljaard, J, additional, Botha, M H, additional, Dramowski, A, additional, Cluver, C A, additional, and Bekker, A, additional

Published
2021
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16. PSG9-A NOVEL BIOMARKER DERANGED IN PREECLAMPSIA

Author

Kandel, M, Walker, S, MacDonald, T, Cluver, C, Bergman, L, Myers, J, Hastie, R, Keenan, E, Cannon, P, Nguyen, T-V, Hannan, N, Pritchard, N, Tong, S, Kaitu'u-Lino, T, Kandel, M, Walker, S, MacDonald, T, Cluver, C, Bergman, L, Myers, J, Hastie, R, Keenan, E, Cannon, P, Nguyen, T-V, Hannan, N, Pritchard, N, Tong, S, and Kaitu'u-Lino, T

Published
2021

17. Circulating Growth Differentiation Factor 15 Is Increased Preceding Preeclampsia Diagnosis: Implications as a Disease Biomarker

Author

Cruickshank, T, MacDonald, TM, Walker, SP, Keenan, E, Dane, K, Middleton, A, Kyritsis, V, Myers, J, Cluver, C, Hastie, R, Bergman, L, Garcha, D, Cannon, P, Murray, E, Nguyen, T-V, Hiscock, R, Pritchard, N, Hannan, NJ, Tong, S, Kaitu'u-Lino, TJ, Cruickshank, T, MacDonald, TM, Walker, SP, Keenan, E, Dane, K, Middleton, A, Kyritsis, V, Myers, J, Cluver, C, Hastie, R, Bergman, L, Garcha, D, Cannon, P, Murray, E, Nguyen, T-V, Hiscock, R, Pritchard, N, Hannan, NJ, Tong, S, and Kaitu'u-Lino, TJ

Abstract

Background We investigated the biomarker potential of growth differentiation factor 15 (GDF-15), a stress response protein highly expressed in placenta, to predict preeclampsia. Methods and Results In 2 prospective cohorts (cohort 1: 960 controls, 39 women who developed preeclampsia; cohort 2: 950 controls, 41 developed preeclampsia), plasma concentrations of GDF-15 at 36 weeks' gestation were significantly increased among those who developed preeclampsia (P<0.001), area under the receiver operating characteristic curves (AUC) of 0.66 and 0.71, respectively. In cohort 2 a ratio of sFlt-1/PlGF (a clinical biomarker for preeclampsia) had a sensitivity of 61.0% at 83.2% specificity to predict those who will develop preeclampsia (AUC of 0.79). A ratio of GDF-15×sFlt-1/PlGF yielded a sensitivity of 68.3% at 83.2% specificity (AUC of 0.82). GDF-15 was consistently elevated across a number of international cohorts: levels were higher in placenta and blood from women delivering <34 weeks' gestation due to preterm preeclampsia in Melbourne, Australia; and in the blood at 26 to 32 weeks' gestation among 57 women attending the Manchester Antenatal Vascular Service (MAViS, UK) who developed preeclampsia (P=0.0002), compared with 176 controls. In the Preeclampsia Obstetric adVerse Events biobank (PROVE, South Africa), plasma GDF-15 was significantly increased in women with preeclampsia with severe features (P=0.02; n=14) compared to controls (n=14). Conclusions We conclude circulating GDF-15 is elevated among women more likely to develop preeclampsia or diagnosed with the condition. It may have value as a clinical biomarker, including the potential to improve the sensitivity of sFlt-1/PlGF ratio.

Published
2021

18. PROVE-Pre-Eclampsia Obstetric Adverse Events: Establishment of a Biobank and Database for Pre-Eclampsia

Author

Bergman, L, Bergman, K, Langenegger, E, Moodley, A, Griffith-Richards, S, Wikstrom, J, Hall, D, Joubert, L, Herbst, P, Schell, S, van Veen, T, Belfort, M, Tong, SYC, Walker, S, Hastie, R, Cluver, C, Bergman, L, Bergman, K, Langenegger, E, Moodley, A, Griffith-Richards, S, Wikstrom, J, Hall, D, Joubert, L, Herbst, P, Schell, S, van Veen, T, Belfort, M, Tong, SYC, Walker, S, Hastie, R, and Cluver, C

Abstract

Pre-eclampsia is a leading cause of maternal and perinatal morbidity and mortality. The burden of disease lies mainly in low-middle income countries. The aim of this project is to establish a pre-eclampsia biobank in South Africa to facilitate research in the field of pre-eclampsia with a focus on phenotyping severe disease.The approach of our biobank is to collect biological specimens, detailed clinical data, tests, and biophysical examinations, including magnetic resonance imaging (MRI) of the brain, MRI of the heart, transcranial Doppler, echocardiography, and cognitive function tests.Women diagnosed with pre-eclampsia and normotensive controls are enrolled in the biobank at admission to Tygerberg University Hospital (Cape Town, South Africa). Biological samples and clinical data are collected at inclusion/delivery and during the hospital stay. Special investigations as per above are performed in a subset of women. After two months, women are followed up by telephonic interviews. This project aims to establish a biobank and database for severe organ complications of pre-eclampsia in a low-middle income country where the incidence of pre-eclampsia with organ complications is high. The study integrates different methods to investigate pre-eclampsia, focusing on improved understanding of pathophysiology, prediction of organ complications, and potentially future drug evaluation and discovery.

Published
2021

20. Severe maternal morbidity in the Asia Pacific: a systematic review and meta-analysis

Author

De Silva, M, Panisi, L, Lindquist, A, Cluver, C, Middleton, A, Koete, B, Vogel, JP, Walker, S, Tong, S, Hastie, R, De Silva, M, Panisi, L, Lindquist, A, Cluver, C, Middleton, A, Koete, B, Vogel, JP, Walker, S, Tong, S, and Hastie, R

Abstract

BACKGROUND: Monitoring rates of severe maternal morbidity (such as eclampsia and uterine rupture) is useful to assess the quality of obstetric care, particularly in low and lower-middle-income countries (LMICs). METHODS: We undertook a systematic review characterising the proportion and causes of severe maternal morbidity in the Asia Pacific region. We searched Medline, Embase, Cochrane CENTRAL library and the World Health Organization Western Pacific Index database for studies in the Asia-Pacific reporting maternal morbidity/near miss using a predefined search strategy. We included cohort, case-control and cross-sectional studies published in English before September 2020. A meta-analysis was performed calculating the overall proportion of near miss events by sub-region, country, near miss definition, economic status, setting and cause using a random-effects model. FINDINGS: We identified 26,232 articles, screened 24,306 and retrieved 454 full text articles. Of these, 197 studies spanning 27 countries were included. 13 countries in the region were not represented. There were 30,183,608 pregnancies and 100,011 near misses included. The total proportion of near miss events was 4•4 (95% CI 4•3-4•5) per 1000 total births. The greatest proportion of near misses were found in the Western Pacific region (around Papua New Guinea) at 11•8 per 1000 births (95% CI 6•6-17•1; I2 96.05%). Low-income countries displayed the greatest proportion of near misses (13•4, 95% CI 6•0-20•7), followed by lower-middle income countries (11•1; 95% CI 10•4 - 11•9). High-income countries had the lowest proportion (2•2, 95% CI 2•1-2•3). Postpartum haemorrhage was the most common near miss event (5•9, 95% CI 4•5-7•2), followed by eclampsia (2•7, 95% CI 2•4 - 2•9). INTERPRETATION: There is a high burden of severe maternal morbidity in the Asia-Pacific. LMICs are disproportionately affected. Most of the common causes are preventable. This provides an opportunity to implement targeted interventions

Published
2021

22. A core outcome set for pre-eclampsia research: an international consensus development study

Author

Duffy, J. M. N., Cairns, A. E., Richards-Doran, D., van 't Hooft, J., Gale, C., Brown, M., Chappell, L. C., Grobman, W. A., Fitzpatrick, R., Karumanchi, S. A., Khalil, A., Lucas, D. N., Magee, L. A., Mol, B. W., Stark, M., Thangaratinam, S., Wilson, M. J., von Dadelszen, P., Williamson, P. R., Ziebland, S., Mcmanus, R. J., Abalos, E. J., C. C. D., Da, Akadr, A. A., Akturk, Z., Allegaert, K., Angel-Muller, E., Antretter, J., Ashdown, H. F., Audibert, F., Auger, N., Aygun, C., Babic, I., Bagga, R., Baker, J. M., Bhakta, P., Bhandari, V., Bhattacharya, S., Blanker, M. H., Bloomfield, F. H., Bof, A., Brennan, S. M., Broekhuijsen, K., Pipkin, E. F. B., Browne, J. L., Browning, R. M., Bull, J. W., Butt, A., Button, D., Campbell, J. P., Campbell, D. M., Carbillon, L., Carthy, S., Casely, E., Cave, J. A., Cecatti, J. G., Chamillard, M. E., Chassard, D., Checheir, N. C., Chulkov, V. S., Cluver, C. A., Crawford, C. F., Daly, M. C., Darmochwal-Kolarz, D. A., Davies, R. E., Davies, M. W., Dawson, J. S., Dobson, N., Dodd, C. N., Donald, F., Duley, L., Epstein-Mares, J., Erez, O., Evans, E., Farlie, R. N., Ferris, A. V., Frankland, E. M., Freeman, D. J., Gainder, S., Ganzevoort, W., Gbinigie, O. A., Ghosh, S. K., Glogowska, M., Goodlife, A., Gough, K. L., Green, J. R., Gul, F., Haggerty, L., Hall, D. R., Hallman, M., Hamilton, L. M., Hammond, S. J., Harlow, S. D., Hays, K. E., Hickey, S. C., Higgins, M., Hinton, L., Hobson, S. R., Hogg, M. J., Hollands, H. J., C. S. E., Eh, Hoodbhoy, Z., Howell, P., Huppertz, B., Husain, S., Jacoby, S. D., Jacqz-Aigrain, E., Jenkins, G., Jewel, D., Johnson, M. J., Johnston, C. L., Jones, P. M., Kantrowitz-Gordon, I., Khan, R. -U., Kirby, L. J., Kirk, C., Knight, M., Korey, M. T., Lee, G. J., Lee, V. W., Levene, L. S., Londero, A. P., Lust, K. M., Mackenzie, V., Malha, L., Mattone, M., Mccartney, D. E., Mcfadden, A., Mckinstry, B. H., Middleton, P. F., Mistry, H. D., Mitchell, C. A., Mockler, J. C., Molsher, S. -A., Monast, E. S., Moodley, E. J., Mooij, R., Moore, E. L., Morgan, L., Moulson, A., Mughal, F., Mundle, S. R., Munoz, M. A., Murray, E., Nagata, C., Nair, A. S., Nakimuli, A., Nath, G., Newport, R. S., Oakeshott, P., Ochoa-Ferraro, M. R., Odendaal, H., Ohkuchi, A., Oliveira, L., Ortiz-Panozo, E., Oudijk, M. A., Oygucu, S. E., Paech, M. J., Painter, R. C., Parry, C. L., Payne, B. A., Pearson, E. L., Phupong, V., Pickett, N., Pickles, K. A., Plumb, L. K., Prefumo, F., Preston, R., Ray, J. G., Rayment, J., Regan, L. V., Rey, E., Robson, E. J., Rubin, A. N., Rubio-Romero, A. N., Rull, K., Sass, N., Sauve, N., Savory, N. A., Scott, J. R., Seaton, S. E., Seed, P. T., Shakespeare, J. M., Shand, A. W., Sharma, S., Shaw, T. Y., Smedley, K. L., Smith, D., Conk, A. S., Soward, D., Stepan, H., Stroumpoulis, K., Surendr, A., Takeda, S., Tan, L., Theriot, B. S., Thomas, H. F., Thompson, K., Thompson, P. I., Thompson, M. J., Toms, L., Torney, K. L. H. T., Treadwell, J. S., Tucker, K. L., Turrentine, M. A., Van Hecke, O., Van Oostwaard, M. F., Vasquez, D. N., D. J. A., Av, Vinturache, A., Walker, J., Wardle, S. P., Wasim, T., Waters, J. H., Whitehead, C. L., Wolfson, A., Yeo, S., Obstetrics and Gynaecology, Life Course Epidemiology (LCE), University of Oxford, University College London, Academic Medical Centre, Imperial College London, St George Hospital and University of New South Wales, King's College London, Northwestern University, Cedars-Sinai Medical Center, St George's University of London, London North West University Healthcare NHS Trust, Monash University, University of Adelaide, Barts and the London School of Medicine and Dentistry, University of Sheffield, University of Liverpool, Centro Rosarino de Estudios Perinatales, Chelsea and Westminster Hospital NHS Foundation Trust, Babcock University, Ailem Academic Counselling, KU Leuven, Universidad Nacional de Colombia, Northwell Health, Université de Montréal, University of Montreal Hospital Centre, Ondokuz Mayis University, Prince Sultan Military Medical City, Chandigarh, University Hospital Limerick, Drexel University, University of Aberdeen, University of Groningen, University of Auckland, Haaglanden Medisch Centrum, Nottingham University Medical School, Utrecht University, King Edward Memorial Hospital for Women, Imperial College Healthcare NHS Trust, Jean-Verdier Hospital, Downland Practice, Universidade Estadual de Campinas (UNICAMP), Université Lyon, University of North Carolina School of Medicine, South Ural State Medical University, Stellenbosch University, Irish Neonatal Health Alliance, University of Rzeszow, Royal Brisbane and Women's Hospital, Nottingham University Hospitals NHS Trust, University Hospitals of Leicester, North Bristol NHS Trust, University of Nottingham, Soroka University Medical Centre Ben Gurion University of the Negev, St George's University Hospitals NHS Foundation Trust, Hospitalsenhed Midt, University of Glasgow, Postgraduate Institute of Medical Education and Research, Amsterdam Universitair Medische Centra, All India Institute of Medical Sciences Patna, Luton and Dunstable University Hospital, Khyber Medical University Institution of Medical Sciences, Midwife Mid Essex Hospitals NHS Trust, University of Oulu, University of Michigan, Bastyr University, Irish Nurses and Midwives Organisation, University of Toronto, Barts Health NHS Trust, University Hospitals Plymouth NHS Trust, Burnet Institute, Aga Khan University, Medical University of Graz, Homerton University Hospital NHS Foundation Trust, Mount Royal University, Université de Paris, Royal Surrey County Hospital, University Hospital Southampton NHS Foundation Trust, University of Washington School of Nursing, Evelina London Children's Hospital Neonatal Unit, University of Sydney, University of Leicester, Academic Hospital of Udine, NHS Borders, Weill Cornell Medical College, University of Dundee, University of Edinburgh, South Australian Health and Medical Research Institute, Monash University and Monash Health, United Lincolnshire Hospitals NHS Trust, University of Kwa Zulu-Natal, Beatrix Hospital, Keele University, Nagpur, Institut Catala de la Salut. IdiapJgol, National Centre for Child Health and Development, Basavatarakam Indo-American Cancer Hospital and Research Institute, Axon Anaesthesia Associates, Pennine Acute Hospitals NHS Trust, University of London, Norfolk and Norwich University Hospital, Jichi Medical University School of Medicine, Universidade Estadual Paulista (UNESP), National Institute of Public Health, University of Kyrenia, King Edward Memorial Hospital, Amsterdam University Centres, University of British Columbia, Chulalongkorn University, University of Brescia, University of Montreal, Women's Clinic of Tartu University Hospital, Universidade Federal de São Paulo (UNIFESP), Université de Sherbrooke, University Hospital of Wales, University of Iowa, Westmead Hospital, Princess Royal Maternity, Leipzig University, Centre Hospitalier Public du Cotentin, Lewisham and Greenwich NHS Trust, Juntendo University Faculty of Medicine, Western Sydney University, National Institute of Health Research, University of Washington, Baylor College of Medicine, Capelle aan den Ijssel, Sanatorio Anchorena, Oxford University Hospitals NHS Foundation Trust, University of Leeds, Lahore, UPMC Magee Womens Hospital, and Penn Medicine Princeton Health

Subjects
PROTOCOL, medicine.medical_specialty, pre-eclampsia, Biomedical Research, Consensus development study, core outcome set, modified Delphi method, modified nominal group technique, outcome reporting bias, Female, Humans, International Cooperation, Pre-Eclampsia, Pregnancy, Pregnancy Outcome, Population, GUIDELINES, RECOMMENDATIONS, Obstetrics and gynaecology, Intensive care, Nominal group technique, medicine, Obstetrics & Reproductive Medicine, Intensive care medicine, education, 11 Medical and Health Sciences, reproductive and urinary physiology, education.field_of_study, Science & Technology, Eclampsia, business.industry, Obstetrics & Gynecology, Obstetrics and Gynecology, Gestational age, medicine.disease, TRIALS, Systematic review, International Collaboration to Harmonise Outcomes for Pre-eclampsia (iHOPE), Thematic analysis, business, Life Sciences & Biomedicine
Abstract

Made available in DSpace on 2022-04-28T19:28:54Z (GMT). No. of bitstreams: 0 Previous issue date: 2020-11-01 National Institute for Health Research Barts Charity Objective: To develop a core outcome set for pre-eclampsia. Design: Consensus development study. Setting: International. Population: Two hundred and eight-one healthcare professionals, 41 researchers and 110 patients, representing 56 countries, participated. Methods: Modified Delphi method and Modified Nominal Group Technique. Results: A long-list of 116 potential core outcomes was developed by combining the outcomes reported in 79 pre-eclampsia trials with those derived from thematic analysis of 30 in-depth interviews of women with lived experience of pre-eclampsia. Forty-seven consensus outcomes were identified from the Delphi process following which 14 maternal and eight offspring core outcomes were agreed at the consensus development meeting. Maternal core outcomes: death, eclampsia, stroke, cortical blindness, retinal detachment, pulmonary oedema, acute kidney injury, liver haematoma or rupture, abruption, postpartum haemorrhage, raised liver enzymes, low platelets, admission to intensive care required, and intubation and ventilation. Offspring core outcomes: stillbirth, gestational age at delivery, birthweight, small-for-gestational-age, neonatal mortality, seizures, admission to neonatal unit required and respiratory support. Conclusions: The core outcome set for pre-eclampsia should underpin future randomised trials and systematic reviews. Such implementation should ensure that future research holds the necessary reach and relevance to inform clinical practice, enhance women's care and improve the outcomes of pregnant women and their babies. Tweetable abstract: 281 healthcare professionals, 41 researchers and 110 women have developed #preeclampsia core outcomes @HOPEoutcomes @jamesmnduffy. [Correction added on 29 June 2020, after first online publication: the order has been corrected.]. Nuffield Department of Primary Care Health Sciences University of Oxford Institute for Women's Health University College London Department of Obstetrics and Gynaecology Amsterdam UMC Academic Medical Centre Academic Neonatal Medicine Imperial College London Department of Renal Medicine St George Hospital and University of New South Wales Department of Women and Children's Health School of Life Course Sciences King's College London Department of Obstetrics and Gynecology Feinberg School of Medicine Northwestern University Health Services Research Unit Nuffield Department of Population Health University of Oxford Cedars-Sinai Medical Center Vascular Biology Research Centre Molecular and Clinical Sciences Research Institute St George's University of London London North West University Healthcare NHS Trust Department of Obstetrics and Gynaecology Monash University Department of Obstetrics and Gynaecology University of Adelaide Women's Health Research Unit Barts and the London School of Medicine and Dentistry School of Health and Related Research University of Sheffield MRC North West Hub for Trials Methodology Research Department of Biostatistics University of Liverpool Centro Rosarino de Estudios Perinatales Chelsea and Westminster Hospital NHS Foundation Trust Babcock University Ailem Academic Counselling KU Leuven Universidad Nacional de Colombia Northwell Health University of Oxford Université de Montréal University of Montreal Hospital Centre Ondokuz Mayis University Prince Sultan Military Medical City Postgraduate Institute of Medical Education and Research Chandigarh University Hospital Limerick Drexel University University of Aberdeen University of Groningen University of Auckland Haaglanden Medisch Centrum Nottingham University Medical School Utrecht University King Edward Memorial Hospital for Women Imperial College Healthcare NHS Trust Jean-Verdier Hospital Downland Practice University of Campinas Université Lyon University of North Carolina School of Medicine South Ural State Medical University Stellenbosch University Irish Neonatal Health Alliance University of Rzeszow Royal Brisbane and Women's Hospital Nottingham University Hospitals NHS Trust University Hospitals of Leicester North Bristol NHS Trust University of Nottingham Soroka University Medical Centre Ben Gurion University of the Negev St George's University Hospitals NHS Foundation Trust Hospitalsenhed Midt University of Glasgow Postgraduate Institute of Medical Education and Research Amsterdam Universitair Medische Centra All India Institute of Medical Sciences Patna Luton and Dunstable University Hospital Khyber Medical University Institution of Medical Sciences Midwife Mid Essex Hospitals NHS Trust University of Oulu University of Michigan Bastyr University Irish Nurses and Midwives Organisation University of Toronto Barts Health NHS Trust University Hospitals Plymouth NHS Trust Burnet Institute Aga Khan University Medical University of Graz Homerton University Hospital NHS Foundation Trust Mount Royal University Université de Paris Royal Surrey County Hospital University Hospital Southampton NHS Foundation Trust University of Washington School of Nursing Evelina London Children's Hospital Neonatal Unit University of Sydney University of Leicester Academic Hospital of Udine NHS Borders Weill Cornell Medical College University of Dundee University of Edinburgh South Australian Health and Medical Research Institute University of Sheffield Monash University and Monash Health United Lincolnshire Hospitals NHS Trust University of Kwa Zulu-Natal Beatrix Hospital Keele University Government Medical College Nagpur Institut Catala de la Salut. IdiapJgol University College London National Centre for Child Health and Development Basavatarakam Indo-American Cancer Hospital and Research Institute Axon Anaesthesia Associates Pennine Acute Hospitals NHS Trust St George's University of London Norfolk and Norwich University Hospital Jichi Medical University School of Medicine São Paulo State University National Institute of Public Health University of Kyrenia King Edward Memorial Hospital Amsterdam University Centres University of British Columbia Chulalongkorn University University of Brescia University of Montreal Women's Clinic of Tartu University Hospital Universidade Federal de São Paulo Université de Sherbrooke University Hospital of Wales University of Iowa King's College London Westmead Hospital Princess Royal Maternity Leipzig University Centre Hospitalier Public du Cotentin Lewisham and Greenwich NHS Trust Juntendo University Faculty of Medicine Western Sydney University National Institute of Health Research University of Washington Baylor College of Medicine Capelle aan den Ijssel Sanatorio Anchorena Oxford University Hospitals NHS Foundation Trust University of Leeds Institute of Medical Sciences Lahore UPMC Magee Womens Hospital Penn Medicine Princeton Health University of North Carolina at Chapel Hill USA and Dr Arnold G. Zermansky University of Leeds São Paulo State University

Published
2020

23. The association of prenatal alcohol exposure on the cognitive abilities and behaviour profiles of 4-year-old children : a prospective cohort study

Author

Cluver, C. A., Charles, W., van der Merwe, C., Bezuidenhout, H., Nel, D., Groenewald, C., Brink, L., Hesselman, Susanne, Bergman, Lina, Odendaal, H., Cluver, C. A., Charles, W., van der Merwe, C., Bezuidenhout, H., Nel, D., Groenewald, C., Brink, L., Hesselman, Susanne, Bergman, Lina, and Odendaal, H.

Abstract

Objective: To examine the association of prenatal alcohol exposure (PAE) on cognitive abilities and behaviour profiles of 4‐year‐old children. Design: Prospective cohort study. Setting: Cape Town, South Africa. Population: A cohort of 500 children. Methods: Children from the Safe Passage Study, which prospectively collected PAE, were included. Cognition and behavioural profiles were assessed. Children with and without PAE were compared. Mean scores were compared, with P ≤ 0.05 considered significant. Results were adjusted for confounding factors. Main outcome measures: The Kaufman Assessment Battery for children measured intellectual and mental ability; the NEPSY‐II instrument assessed neurocognitive performance. The caregiver completed the Preschool Child Behaviour checklist to rate the child’s problem behaviours and competencies. Results: Two hundred children had no PAE, 117 children had mild to moderate PAE (with no binge episodes), 113 children had heavy PAE (with one or two binge episodes), and 70 children had very heavy PAE (with three or more binge episodes). Women who binge drank had significantly higher rates of smoking, marijuana use, and methamphetamine use. Low to moderate PAE had no effect on cognitive ability and behaviour. Very heavy PAE was associated with problems performing simultaneous as well as sequential functions, lower scores in the language and sensorimotor domain, and more attention and pervasive developmental problems. Conclusions: Low to moderate PAE was not associated with cognitive processing or developmental problems. Women who had many binge drinking episodes during pregnancy were the most at risk for cognitive processing, neurocognitive, and behaviour problems in their children at 4 years of age. Tweetable abstract: Low to moderate prenatal alcohol use was not associated with cognitive or behavioural problems in 4‐year‐olds.

Published
2019
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24. A double blind, randomised, placebo-controlled trial to evaluate the efficacy of metformin to treat preterm pre-eclampsia (PI2 Trial): study protocol

Author

Cluver, C, Walker, SP, Mol, BW, Hall, D, Hiscock, R, Brownfoot, FC, Kaitu'u-Lino, TJ, Tong, S, Cluver, C, Walker, SP, Mol, BW, Hall, D, Hiscock, R, Brownfoot, FC, Kaitu'u-Lino, TJ, and Tong, S

Abstract

INTRODUCTION: Pre-eclampsia is a major complication of pregnancy, globally responsible for 60 000 maternal deaths per year, and far more fetal losses. There is no definitive treatment other than delivery. A therapeutic that could quench the disease process would be useful to treat preterm pre-eclampsia, as it could allow these pregnancies to safely continue to a gestation where fetal outcomes are significantly improved. We have published preclinical data to show that metformin, a drug known to be safe in pregnancy and commonly used to treat gestational diabetes, has potent biological effects making it another promising candidate to treat pre-eclampsia. Here, we describe a phase II clinical trial to examine whether administering extended-release metformin may be effective in treating women with preterm pre-eclampsia (PI2 Trial). METHODS: The PI2 Trial is a phase II, double blind, randomised controlled trial that aims to recruit 150 women with preterm pre-eclampsia (gestational age 26+0 to 31+6 weeks) who are being managed expectantly. Participants will be randomised to receive either 3 g of metformin or placebo daily. The primary outcome is time from randomisation until delivery. A delay in delivery of 5 days is assumed to be clinically relevant. The secondary outcomes will be a maternal composite and neonatal composite outcome. All other outcomes will be exploratory. We will record adverse events. ETHICS AND DISSEMINATION: This study has ethical approval (Protocol number M16/09/037 Federal Wide Assurance Number 00001372, Institutional Review Board Number IRB0005239), is registered with the Pan African Clinical Trial Registry (PACTR201608001752102) and the South African Medicine Control Council (20170322). Data will be presented at international conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: PACTR201608001752102; Pre-results.

Published
2019

25. The association of prenatal alcohol exposure on the cognitive abilities and behaviour profiles of 4-year-old children: a prospective cohort study.

Author

Cluver, CA, Charles, W, Merwe, C, Bezuidenhout, H, Nel, D, Groenewald, C, Brink, L, Hesselman, S, Bergman, L, Odendaal, H, Cluver, C A, and van der Merwe, C

Subjects
COGNITIVE ability, LONGITUDINAL method, BINGE drinking, COHORT analysis, ALCOHOL drinking, BEHAVIOR
Abstract

Objective: To examine the association of prenatal alcohol exposure (PAE) on cognitive abilities and behaviour profiles of 4-year-old children.Design: Prospective cohort study.Setting: Cape Town, South Africa.Population: A cohort of 500 children.Methods: Children from the Safe Passage Study, which prospectively collected PAE, were included. Cognition and behavioural profiles were assessed. Children with and without PAE were compared. Mean scores were compared, with P ≤ 0.05 considered significant. Results were adjusted for confounding factors.Main Outcome Measures: The Kaufman Assessment Battery for children measured intellectual and mental ability; the NEPSY-II instrument assessed neurocognitive performance. The caregiver completed the Preschool Child Behaviour checklist to rate the child's problem behaviours and competencies.Results: Two hundred children had no PAE, 117 children had mild to moderate PAE (with no binge episodes), 113 children had heavy PAE (with one or two binge episodes), and 70 children had very heavy PAE (with three or more binge episodes). Women who binge drank had significantly higher rates of smoking, marijuana use, and methamphetamine use. Low to moderate PAE had no effect on cognitive ability and behaviour. Very heavy PAE was associated with problems performing simultaneous as well as sequential functions, lower scores in the language and sensorimotor domain, and more attention and pervasive developmental problems.Conclusions: Low to moderate PAE was not associated with cognitive processing or developmental problems. Women who had many binge drinking episodes during pregnancy were the most at risk for cognitive processing, neurocognitive, and behaviour problems in their children at 4 years of age.Tweetable Abstract: Low to moderate prenatal alcohol use was not associated with cognitive or behavioural problems in 4-year-olds. [ABSTRACT FROM AUTHOR]

Published
2019
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26. Heme Oxygenase-1 Is Not Decreased in Preeclamptic Placenta and Does Not Negatively Regulate Placental Soluble fms-Like Tyrosine Kinase-1 or Soluble Endoglin Secretion

Author

Tong, S, Kaitu'u-Lino, TJ, Onda, K, Beard, S, Hastie, R, Binder, NK, Cluver, C, Tuohey, L, Whitehead, C, Brownfoot, F, De Silva, M, Hannan, NJ, Tong, S, Kaitu'u-Lino, TJ, Onda, K, Beard, S, Hastie, R, Binder, NK, Cluver, C, Tuohey, L, Whitehead, C, Brownfoot, F, De Silva, M, and Hannan, NJ

Abstract

Elevated placental release of the antiangiogenic factors, soluble fms-like tyrosine kinase-1 (sFlt-1) and soluble endoglin (sENG), is central to the pathophysiology of preeclampsia. It is widely accepted that heme oxygenase-1 (HO-1) is decreased in preeclamptic placenta and negatively regulates sFlt-1 and sENG production. We set out to verify these contentions. There was no difference in HO-1 mRNA or protein levels in preterm preeclamptic placentas (n=17) compared with gestationally matched controls (n=27). In silico analysis of microarray studies did not identify decreased placental HO-1 expression in preeclamptic placenta. Silencing HO-1 in primary trophoblasts did not affect sFlt-1 protein secretion after 24 or 48 hours. Silencing nuclear factor (erythroid-derived 2)-like 2 (transcription factor that upregulates HO-1) in trophoblasts also did not affect sFlt-1 secretion. Administering tin protoporphyrin IX dichloride (HO-1 inhibitor) or cobalt protoporphyrin (HO-1 inducer) into placental explants did not affect sFlt-1 or sENG secretion. Silencing HO-1 in 2 types of primary endothelial cells (human umbilical vein endothelial and uterine microvascular endothelial cells) significantly increased sFlt-1 secretion but not sENG secretion. However, HO-1 silencing selectively increased mRNA expression of sFlt-1 i13 (generically expressed sFlt-1 variant) but not of sFlt-1 e15a (sFlt-1 variant mainly expressed in placenta). Furthermore, adding tin protoporphyrin IX dichloride decreased sFlt-1, whereas adding HO-1 inducers (cobalt protoporphyrin, dimethyl fumarate, and rosiglitazone) either had no effect or increased sFlt-1 or sENG secretion (these trends are opposite to what is expected). We conclude that HO-1 expression is not decreased in preeclamptic placenta and HO-1 does not negatively regulate placental sFlt-1 and sENG secretion in placental or endothelial cells.

Published
2015

29. Sepsis: Primary indication for peripartum hysterectomies in a South African setting.

Author

van Vuuren, L. Jansen and Cluver, C. A.

Subjects
*SEPSIS, *HYSTERECTOMY, *UTERINE rupture, *PLACENTA, *HIV infections, *MEDICAL care
Abstract

Background. Peripartum hysterectomies are lifesaving procedures but definitions vary. Indications are variable and dependant on resources and geographical factors. Objectives. To evaluate the incidence, aetiology and complications associated with peripartum hysterectomies in a tertiary hospital in South Africa. Methods. A retrospective audit at an academic referral centre over a 5-year period from February 2009 to March 2014 was performed. Procedures from a gestation of 24 weeks until 6 weeks postpartum were included. Results. One hundred and sixty cases met inclusion criteria. Nine case records were unavailable. The incidence was 2.77 per 1 000 deliveries. Main indications were sepsis (60, 39.7%), atony (24, 15.9%), morbidly adherent placenta (21, 13.9%), tears (14, 9.3%), uterine rupture (8, 5.3%), placenta praevia (7, 4.6%) and unclassified bleeding (6, 4.0%). There were 6 maternal deaths. Five related to sepsis and one to hypovolaemic shock. One hundred and thirty-eight (91.4%) women required high or intensive care admission. Conclusion. Sepsis is an important aetiology for peripartum hysterectomies, particularly in southern Africa. The high rate of sepsis may be due to HIV infection, low socioeconomic standards, late diagnosis, limited access to healthcare, sterility issues and differences in the definition and inclusion criteria used for a peripartum hysterectomy. [ABSTRACT FROM AUTHOR]

Published
2016
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31. Uterine artery embolisation for uterine leiomyomas.

Author

Lawson, A., Cluver, C., Olarogun, J., Legge, D., Patel, M., Beningeld, S., and Dyer, S.

Subjects
*UTERINE artery, *UTERINE fibroids, *MAGNETIC resonance imaging, *INFERTILITY, *MENORRHAGIA, *ENDOMETRIOSIS
Abstract

Background. Many forms of minimally invasive treatment have gained substantial popularity, both with the medical fraternity and the public. With the correct clinical indications and in skilled hands, uterine artery embolisation (UAE) has been accepted internationally as part of the standard of care that should be offered to patients with symptomatic uterine leiomyomas (fibroids). Objectives. To introduce UAE as an effective and safe treatment option in patients with symptomatic fibroids in the Western Cape Provincial Service, South Africa. Methods. Setting: Groote Schuur and Tygerberg hospitals, Western Cape. Design: Prospective observational multi-centre study. Methods: 36 women (mean age 38 years, range 30 - 47 years) with symptomatic fibroids were treated with UAE between November 2009 and February 2012. Pre-procedure magnetic resonance imaging (MRI) followed by a 6-month clinical follow-up plus MRI or an ultrasound scan were performed. Results. The presenting symptoms were menorrhagia, dysmenorrhoea, pressure symptoms and intermenstrual bleeding. Three women were treated for primary infertility. Uterine artery sub-selection and embolisation was successful in all patients. Complications included low-grade pyrexia (3/36, 8.3%) and readmission (1/36, 2.8%). The average reduction in uterine volume at 6 months was 50%. At followup (mean 15 months, range 7 - 32), 91.7% (33/36) had complete symptomatic resolution and 83.3% (30/36) were 'completely satisfied'. Participants treated for primary infertility and concurrent adenomyosis did not receive any benefit from UAE. Conclusion. Uterine artery embolisation is associated with a high clinical success rate. This study suggests that UAE should be offered as an attractive alternative to surgery in our practice [ABSTRACT FROM AUTHOR]

Published
2014
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32. Breech presentation: The controversy continues.

Author

Cluver, C. A. and Hofmeyr, G. J.

Subjects
*BREECH delivery, *CESAREAN section, *FETAL presentation, *DELIVERY (Obstetrics), *TOCOLYTIC agents, *REPRODUCTIVE health
Abstract

The management of a breech presentation has and will always be a controversial topic. In this review article we discuss the classification of breech presentations and the associated risks. We review the recent literature regarding the management options which include awaiting a spontaneous version, performing an external cephalic version (ECV) and the options to facilitate a successful version. We discuss the role of elective caesarean section (CS) versus vaginal delivery with regard to recent literature. We conclude that ECV should be offered to all women with a breech presentation who do not have contraindications as it is effective and safe and that an ECV should be performed using a betamimetic for tocolysis. If an ECV is unsuccessful then the route of delivery for a persistent breech presentation should be individualised. Women with a breech presentation should be extensively counselled about the different delivery options and they should be provided with all the evidence, including the limitations of the evidence. The risks associated with caesarean section including the risk to future pregnancies must be emphasised as this enables a women to make an informed decision about their delivery. Vaginal delivery for certain selected breech presentations is still a good option. For women with a baby with flexed thighs who progress appropriately in labour with descent and spontaneous birth of the breech, the likelihood of difficulty with the delivery is very small. If progress is not good, even at full cervical dilation, recourse to CS is a safer option than attempts at breech extraction. Training videos are available in the World Health Organization Reproductive Health Library on the delivery of a breech presentation and on the technique of ECV (http://apps.who.int/rhl/videos/en/index.html). [ABSTRACT FROM AUTHOR]

Published
2012

33. Posterior axilla sling traction for intractable shoulder dystocia.

Author

Hofmeyr, G. J. and Cluver, C. A.

Subjects
*CASE studies, *SHOULDER dystocia, *LABOR complications (Obstetrics), *CHILDBIRTH, *THERAPEUTICS
Abstract

The article presents case studies related to shoulder dystocia. Under these cases, several techniques to overcome shoulder dystocia including McRoberts' maneuver, application of suprapubic pressure, posterior head traction, and rotational manipulation of the baby, were attempted but unsuccessful. Ultimately, the shoulder dystocia was overcome by catheter sling traction around the posterior axilla.

Published
2009
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35. Trisomy 21 screening with αlpha software and the Fetal Medicine Foundation algorithm.

Author

Pistorius L, Cluver CA, Bhorat I, and Geerts L

Subjects
Pregnancy, Humans, Female, Perinatology, Ultrasonography, Prenatal methods, South Africa, Prenatal Diagnosis, Algorithms, Software, Down Syndrome diagnosis, Down Syndrome epidemiology
Abstract

Background: Screening for trisomy 21 provides pregnant women with accurate risk information. Different algorithms are used to screen for trisomy 21 in South Africa (SA). The Fetal Medicine Foundation (FMF) provides software to screen for trisomy 21 in the first trimester by ultrasound or a combination of ultrasound and biochemistry (combined screening), and requires regular and stringent quality control. With αlpha software, first trimester combined screening and screening with biochemistry alone in the first or second trimester are possible. The αlpha screening requires quality control of biochemical tests, but not of ultrasound measurements. Ideally, a screening test should have a high detection and a low screen positive rate. Despite the availability of these screening programmes, only a minority of infants with trisomy 21 are detected prenatally, raising questions about the effectiveness of screening., Objectives: To determine the screen positive and detection rates of prenatal screening for trisomy 21 in the SA private healthcare system., Methods: Data from the three largest laboratories collected between 2010 and 2015 were linked with genetic tests to assess screen positive and detection rates. Biochemical screening alone with αlpha software (first or second trimester) and combined screening using either FMF or αlpha software were compared., Results: One-third of an estimated 675 000 pregnancies in private practice in the 6-year study period underwent screening. There were 687 cases of trisomy 21 in 225 021 pregnancies, with only 239 (35%) diagnosed prenatally. The screen positive rates were 11.8% for first trimester biochemistry, 7.6% for second trimester biochemistry, 7.3% for first trimester FMF software ultrasound alone, 3.7% for combined first trimester screening with FMF software, and 3.5% for combined first trimester screening with αlpha software. The detection rates for a 5% false positive rate were 63% for first trimester biochemistry, 69% for second trimester biochemistry, 95% for combined first trimester screening with FMF software and 80% for combined first trimester screening with αlpha software. Detection and confirmation rates were highest with FMF software., Conclusion: Screening with FMF software has a similar screen positive rate and better detection rate than screening with αlpha software. The low prenatal detection rate of trisomy 21 is mainly due to a low prevalence of screening. More research is needed in the SA setting to explore why screening and confirmatory testing after high-risk results are not performed in many pregnancies.

Published
2023
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36. Persistent reversed end diastolic flow in the fetal middle cerebral artery: an ominous finding.

Author

Brownfoot FC, Cluver CA, and Walker SP

Abstract

Fetal persistent middle cerebral artery reversed end diastolic flow is a rare and ominous finding. Previous cases have been associated with intracranial hemorrhage, growth restriction, anaemia, and hepatic anomaly. Intrauterine demise or early neonatal death is a common outcome. We report the case of persistent middle cerebral artery reversed end diastolic flow in a well-grown fetus at 32 weeks' gestation resulting from acute, severe anaemia due to a large feto-maternal hemorrhage. An emergency cesarean section was performed and the neonate required advanced resuscitation and immediate blood transfusion. Postnatal magnetic resonance imaging confirmed a hemorrhagic parietal infarct and bilateral ischaemic changes in the basal ganglia. This provides further evidence that persistent middle cerebral artery reversed end diastolic flow in any fetus is an ominous finding warranting urgent diagnostic evaluation and/or delivery.

Published
2015
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