Planned early delivery for late preterm pre-eclampsia in a low- and middle-income setting: a feasibility study.
Planned early delivery for late preterm pre-eclampsia in a low- and middle-income setting: a feasibility study.
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DOI：
10.1186/s12978-021-01159-y
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发表时间：
2021-06-02
影响因子：
3.4
通讯作者：
Shennan AH
中科院分区：
文献类型：
--
作者：
Beardmore-Gray A;Vousden N;Silverio SA;Charantimath U;Katageri G;Bellad M;Chinkoyo S;Vwalika B;Goudar S;Sandall J;Chappell LC;Shennan AH
先兆子痫是全球孕产妇和围产期死亡率和发病率的主要原因。34+0和36+6周之间的计划分娩可能会减少不良妊娠结局，但在中低收入环境中尚未进行评估。在设计一项随机对照试验以评估印度和赞比亚的情况之前，我们进行了为期6个月的可行性研究，以更好地了解拟议的试验环境并指导我们干预措施的开发。我们使用混合方法来了解疾病负担和目前的管理先兆子痫在我们建议的试验地点，并探讨干预的可接受性。我们对在3个月内在拟议的试验地点分娩的先兆子痫妇女进行了病例记录审查，同时促进与妇女和伴侣的焦点小组讨论，并与医疗保健提供者进行半结构化访谈。使用描述性统计分析审计数据。定性数据采用专题框架分析。病例记录数据（n = 326）显示，在我们的环境中，19.5%（n = 44）的先兆子痫分娩超过34周的妇女经历了不良结局。在34+0和36+6周之间分娩的妇女中，产前死产[n = 3（3.3%）]和新生儿死亡[n = 3（3.4%）]的数量相似;赞比亚和印度的婴儿出生体重中位数分别为2.2 kg和1.9 kg。妇女和医疗保健提供者的生活经验是拟议干预的重要促进因素，突出了先兆子痫的严重后果。对自然分娩的偏好和有限的新生儿资源被认为是潜在的障碍。这项研究表明，明确需要评估干预措施，并强调了与试验背景相关的几个挑战，使我们能够调整方案并设计可接受的干预措施。我们的研究表明，在制定复杂的干预措施时，评估可行性的重要性，特别是在低资源环境中。此外，它提供了一个独特的见解先兆子痫的管理在我们的试验设置和知识的理解，态度和信念的基础上的可接受性计划的早期交付。在线版本包含补充材料，可在10.1186/s12978-021-01159-y获得。先兆子痫是妊娠并发症，是世界各地妇女和婴儿与妊娠有关的死亡和严重疾病的主要原因之一。这些死亡大多发生在非洲和亚洲的低收入国家。先兆子痫的症状包括高血压和尿液中的蛋白质。它是不可预测的，如果管理不善，可能会影响女性体内的不同器官，导致癫痫发作、中风甚至死亡。它也会影响婴儿的生长，在严重的情况下会导致死胎。我们知道婴儿（和胎盘）的出生是先兆子痫的唯一治愈方法。目前，世界卫生组织建议，所有患有先兆子痫的妇女在怀孕37周后都应计划早产，除非她们出现严重的并发症，需要在此之前进行干预。然而，来自高收入国家的研究表明，从怀孕34周开始有计划地早产可能会减少妇女的严重并发症，而不会对婴儿造成伤害。我们正在设计一项临床试验，以确定在妊娠34至37周之间患有先兆子痫的妇女中，是否更好地提供有计划的早期分娩或提供密切监测，直到她们达到37周，或者出现需要紧急干预的并发症。在设计本试验之前，我们进行了一项研究，以确定在印度和赞比亚的潜在试验中心进行主要试验是否可行，以及当地社区是否接受。在线版本包含补充材料，可在10.1186/s12978-021-01159-y获得。
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. 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. 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. 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. The online version contains supplementary material available at 10.1186/s12978-021-01159-y. 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. Most of these deaths occur in lower income countries in Africa and Asia. Signs of pre-eclampsia include high blood pressure and protein in the urine. It is unpredictable and may affect different organs within the woman, leading to seizures, stroke and even death if not well managed. It can also affect the baby’s growth and in severe cases lead to stillbirth. We know that birth of the baby (and placenta) is the only cure for pre-eclampsia. Currently, 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. However, research from higher income countries has shown that planned early birth from 34 weeks of pregnancy may reduce serious complications in the woman, without causing harm to the baby. We are designing a clinical trial to find out whether, in women with pre-eclampsia between 34 and 37 weeks of pregnancy, it is better to offer planned early birth or to offer close monitoring until either they reach 37 weeks, or a complication develops requiring emergency intervention. Before designing this trial, we carried out a study in order to establish whether the main trial would be possible, and acceptable to the local community, at our potential trial sites in India and Zambia. The online version contains supplementary material available at 10.1186/s12978-021-01159-y.
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