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Planned early delivery for late preterm pre-eclampsia in a low- and middle-income setting: A feasibility study

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Alice Beardmore-Gray, Nicola Vousden, Sergio A Silverio, Umesh Charantimath, Geetanjali Katageri, Mrutyunjaya Bellad, Sebastian Chinkoyo, Bellington Vwalika, Shivaprasad Goudar, Jane Sandall, Lucy C Chappell, Andrew H Shennan

Original languageEnglish
Article number110
Pages (from-to)1-17
JournalReproductive Health
Volume18
Issue number1
DOIs
Published2 Jun 2021

Bibliographical note

Funding Information: The CRADLE-4 Trial is funded by the UK Medical Research Council in conjunction with the Indian Department of Biotechnology (project reference MR/R021376/1). The study sponsor and funding source have had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results. Funding Information: We would like to acknowledge the CRADLE-4 research team for their contribution to this work: Mercy Kopeka, University Teaching Hospital, Zambia. Josephine Miti, University Teaching Hospital, Zambia. Christine Jere, Ndola Teaching Hospital, Zambia. Chipo Hamweemba, Ndola Teaching Hospital, Zambia. Chandrappa C Karadiguddi, KLE University’s J N Medical College, India. Geetanjali M Mungarwadi, KLE Univeristy’s J N Medical College, India. Jane Sandall at King’s College is an NIHR Senior Investigator and with Sergio Silverio is supported by the National Institute for Health Research (NIHR) Applied Research Collaboration South London (NIHR ARC South London) at King’s College Hospital NHS Foundation Trust. The views expressed are those of the author[s] and not necessarily those of the NIHR or the Department of Health and Social Care. Publisher Copyright: © 2021, The Author(s). Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

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Abstract

Background

Pre-eclampsia is a leading cause of maternal and perinatal mortality and morbidity globally. Planned delivery between 34+0 and 36+6 weeks may reduce adverse pregnancy outcomes but is yet to be evaluated in a low and middle-income setting. Prior to designing a randomised controlled trial to evaluate this in India and Zambia, we carried out a 6-month feasibility study in order to better understand the proposed trial environment and guide development of our intervention.
Methods

We used mixed methods to understand the disease burden and current management of pre-eclampsia at our proposed trial sites and explore the acceptability of the intervention. We undertook a case notes review of women with pre-eclampsia who delivered at the proposed trial sites over a 3-month period, alongside facilitating focus group discussions with women and partners and conducting semi-structured interviews with healthcare providers. Descriptive statistics were used to analyse audit data. A thematic framework analysis was used for qualitative data.
Results

Case notes data (n = 326) showed that in our settings, 19.5% (n = 44) of women with pre-eclampsia delivering beyond 34 weeks experienced an adverse outcome. In women delivering between 34+0 and 36+6 weeks, there were similar numbers of antenatal stillbirths [n = 3 (3.3%)] and neonatal deaths [n = 3 (3.4%)]; median infant birthweight was 2.2 kg and 1.9 kg in Zambia and India respectively. Lived experience of women and healthcare providers was an important facilitator to the proposed intervention, highlighting the serious consequences of pre-eclampsia. A preference for spontaneous labour and limited neonatal resources were identified as potential barriers.
Conclusions

This study demonstrated a clear need to evaluate the intervention and highlighted several challenges relating to trial context that enabled us to adapt our protocol and design an acceptable intervention. Our study demonstrates the importance of assessing feasibility when developing complex interventions, particularly in a low-resource setting. Additionally, it provides a unique insight into the management of pre-eclampsia at our trial settings and an understanding of the knowledge, attitudes and beliefs underpinning the acceptability of planned early delivery.

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