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      Planned early delivery versus expectant management to reduce adverse pregnancy outcomes in pre-eclampsia in a low- and middle-income setting: study protocol for a randomised controlled trial (CRADLE-4 Trial)

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          Abstract

          Background

          Pre-eclampsia is a pregnancy complication characterised by high blood pressure and multi-organ dysfunction in the mother. It is a leading contributor to maternal and perinatal mortality, with 99% of these deaths occurring in low- and middle-income countries (LMIC). Whilst clear guidelines exist for management of early-onset (< 34 weeks) and term (≥ 37 weeks) disease, the optimal timing of delivery in pre-eclampsia between 34 + 0 and 36 + 6 weeks is less clear. In a high-income setting, delivery may improve maternal outcomes without detriment to the baby, but this intervention is yet to be evaluated in LMIC.

          Methods

          The CRADLE-4 Trial is a non-masked, randomised controlled trial comparing planned early delivery (initiation of delivery within 48 h of randomisation) with routine care (expectant management) in women with pre-eclampsia between 34 + 0 and 36 + 6 weeks’ gestation in India and Zambia. The primary objective is to establish whether a policy of planned early delivery can reduce adverse maternal outcomes, without increasing severe neonatal morbidity.

          Discussion

          The World Health Organization recommends delivery for all women with pre-eclampsia from 37 weeks onwards, based on evidence showing clear maternal benefit without increased neonatal risk. Before 34 weeks, watchful waiting is preferred, with delivery recommended only when there is severe maternal or fetal compromise, due to the neonatal risks associated with early preterm delivery. Currently, there is a lack of guidance for clinicians managing women with pre-eclampsia between 34 + 0 and 36 + 6 weeks. Early delivery benefits the mother but may increase the need for neonatal unit admission in the infant (albeit without serious morbidity at this gestation). On the other hand, waiting to deliver may increase the risk of stillbirth, fetal growth restriction and hypoxic brain injury in the neonate as a result of severe maternal complications. This is especially true for LMIC where there is a higher prevalence of adverse events. The balance of risks and benefits therefore needs to be carefully assessed before making firm recommendations. This is the first trial evaluating the optimal timing of delivery in pre-eclampsia in LMIC, where resources and disease burden are considerably different.

          Trial registration

          ISRCTN 10672137. Registered on 28 November 2019.

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          Most cited references18

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          Assessment of coma and impaired consciousness. A practical scale.

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            Hypertensive Disorders of Pregnancy

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              Pre-eclampsia.

              Pre-eclampsia remains a leading cause of maternal and perinatal mortality and morbidity. It is a pregnancy-specific disease characterised by de-novo development of concurrent hypertension and proteinuria, sometimes progressing into a multiorgan cluster of varying clinical features. Poor early placentation is especially associated with early onset disease. Predisposing cardiovascular or metabolic risks for endothelial dysfunction, as part of an exaggerated systemic inflammatory response, might dominate in the origins of late onset pre-eclampsia. Because the multifactorial pathogenesis of different pre-eclampsia phenotypes has not been fully elucidated, prevention and prediction are still not possible, and symptomatic clinical management should be mainly directed to prevent maternal morbidity (eg, eclampsia) and mortality. Expectant management of women with early onset disease to improve perinatal outcome should not preclude timely delivery-the only definitive cure. Pre-eclampsia foretells raised rates of cardiovascular and metabolic disease in later life, which could be reason for subsequent lifestyle education and intervention. Copyright 2010 Elsevier Ltd. All rights reserved.
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                Author and article information

                Contributors
                alice.1.beardmore-gray@kcl.ac.uk
                nicola.vousden@kcl.ac.uk
                drumesh.charantimath@gmail.com
                katagerigm@gmail.com
                mbbellad@hotmail.com
                mutesukunda@yahoo.com
                seb.chinkoyo@yahoo.com
                vwalikab@gmail.com
                matthew.clark1@nhs.net
                r.hunter@ucl.ac.uk
                paul.seed@kcl.ac.uk
                sgoudar@JNMC.edu
                lucy.chappell@kcl.ac.uk
                andrew.shennan@kcl.ac.uk
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                23 November 2020
                23 November 2020
                2020
                : 21
                : 960
                Affiliations
                [1 ]GRID grid.13097.3c, ISNI 0000 0001 2322 6764, Department of Women and Children’s Health, , School of Life Course Sciences, King’s College London, ; London, UK
                [2 ]GRID grid.414956.b, ISNI 0000 0004 1765 8386, Women’s and Children’s Health Research Unit, , KLE Academy of Higher Education and Research, JNMC, ; Belagavi, Karnataka India
                [3 ]GRID grid.496653.b, BVV Sangha’s S Nijalingappa Medical College & HSK Hospital and Research Centre, ; Bagalkot, Karnataka India
                [4 ]GRID grid.12984.36, ISNI 0000 0000 8914 5257, Department of Paediatrics, , University of Zambia, ; Lusaka, Zambia
                [5 ]Department of Obstetrics and Gynaecology, Ndola Teaching Hospital, Ndola, Zambia
                [6 ]GRID grid.12984.36, ISNI 0000 0000 8914 5257, Department of Obstetrics and Gynaecology, , University of Zambia, ; Lusaka, Zambia
                [7 ]Welbodi Partnership, Ola During Children’s Hospital, Freetown, Sierra Leone
                [8 ]GRID grid.83440.3b, ISNI 0000000121901201, Research Department of Primary Care and Population Health, , Royal Free Campus, University College London, ; London, UK
                Author information
                http://orcid.org/0000-0001-9923-4912
                Article
                4888
                10.1186/s13063-020-04888-w
                7684962
                33228794
                38e3d446-ec89-4940-81e2-b96879aef276
                © The Author(s) 2020

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 29 July 2020
                : 11 November 2020
                Funding
                Funded by: Medical Research Council (UK)
                Award ID: MR/R021376/1
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2020

                Medicine
                pre-eclampsia,hypertension,pregnancy,perinatal,global health,low- and middle-income countries
                Medicine
                pre-eclampsia, hypertension, pregnancy, perinatal, global health, low- and middle-income countries

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