Abstract
BackgroundPre-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.MethodsWe 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.ResultsCase 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.ConclusionsThis 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.
Highlights
Pre-eclampsia is a leading cause of maternal and perinatal mortality and morbidity globally
Pre-eclampsia is a complication of pregnancy and is one of the major causes of pregnancy-related death and serious illness for women and babies around the world
It is recommended by the World Health Organisation that all women with pre-eclampsia are offered planned early birth once they reach 37 weeks of pregnancy, unless they develop severe complications needing intervention sooner than this
Summary
Pre-eclampsia is a leading cause of maternal and perinatal mortality and morbidity globally. There is a lack of research into interventions which could be implemented in these regions in order to improve pregnancy outcomes One such intervention, planned early delivery, has been shown to reduce adverse maternal outcomes in a high-income setting [5, 6], but is yet to be evaluated in a LMIC setting. It is widely recognised that conducting an assessment of feasibility is an essential step prior to the development and evaluation of a healthcare intervention as part of a larger-scale clinical trial [7, 8] We designed this initial feasibility study in order to understand the contextual factors likely to influence trial implementation and assess the perceived barriers and facilitators to the intervention. We anticipate that the results of this study would not just optimise delivery of the trial itself, and improve the external validity of any significant trial findings such that they are generalisable to similar settings and practicable to implement in a realworld environment
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