Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Goteborg, Sweden.
Department of Anaesthesiology and Intensive Care, Institute of clinical sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
BMJ Open. 2021 Nov 24;11(11):e049559. doi: 10.1136/bmjopen-2021-049559.
Pre-eclampsia, a multisystem disorder in pregnancy, is one of the most common causes of maternal morbidity and mortality worldwide. However, we lack methods for objective assessment of organ function in pre-eclampsia and predictors of organ impairment during and after pre-eclampsia. The women's and their partners' experiences of pre-eclampsia have not been studied in detail. To phenotype different subtypes of the disorder is of importance for prediction, prevention, surveillance, treatment and follow-up of pre-eclampsia.The aim of this study is to set up a multicentre database and biobank for pre-eclampsia in order to contribute to a safer and more individualised treatment and care.
This is a multicentre cohort study. Prospectively recruited pregnant women ≥18 years, diagnosed with pre-eclampsia presenting at Sahlgrenska University Hospital, Uppsala University Hospital and at Södra Älvsborgs Hospital, Sweden, as well as normotensive controls are eligible for participation. At inclusion and at 1-year follow-up, the participants donate biosamples that are stored in a biobank and they are also asked to participate in various organ-specific evaluations. In addition, questionnaires and interviews regarding the women's and partner's experiences are distributed at follow-up.
By creating a database and biobank, we will provide the means to explore the disorder in a broader sense and allow clinical and laboratory discoveries that can be translated to clinical trials aiming at improved care of women with pre-eclampsia. Further, to evaluate experiences and the psychological impact of being affected by pre-eclampsia can improve the care of pregnant women and their partners. In case of incidental pathological findings during examinations performed, they will be handled in accordance with clinical routine. Data are stored in a secure online database. Biobank samples are identified through the women's personal identification number and pseudonymised after identification in the biobank before analysis.This study was approved by the regional ethical review board in Gothenburg on 28 December 2018 (approval number 955-18) and by the Swedish Ethical Review Authority on 27 February 2019 (approval number 2019-00309).Results from the study will be published in international peer-reviewed journals.
ISRCTN13060768.
子痫前期是一种妊娠多系统疾病，是全球孕产妇发病率和死亡率升高的最常见原因之一。然而，我们缺乏客观评估子痫前期器官功能的方法，也缺乏预测子痫前期及其后器官损害的指标。尚未详细研究女性及其伴侣对子痫前期的体验。对子痫前期不同亚型进行表型分析对于预测、预防、监测、治疗和随访子痫前期具有重要意义。本研究旨在建立一个多中心子痫前期数据库和生物样本库，以促进更安全、更个体化的治疗和护理。
这是一项多中心队列研究。符合条件的参与者为年龄≥ 18 岁、在瑞典哥德堡萨尔格伦斯卡大学医院、乌普萨拉大学医院和南瑞典省阿尔夫斯堡医院诊断为子痫前期的孕妇，以及血压正常的对照组。在纳入时和 1 年随访时，参与者捐赠生物样本，这些样本被储存在生物样本库中，还被邀请参加各种器官特异性评估。此外，在随访时还会发放关于女性及其伴侣体验的问卷和访谈。
通过创建一个数据库和生物样本库，我们将提供更广泛地探索该疾病的手段，并允许进行临床和实验室发现，这些发现可以转化为临床试验，以改善子痫前期女性的护理。此外，评估女性及其伴侣受子痫前期影响的体验和心理影响，可以改善孕妇及其伴侣的护理。如果在进行的检查中发现偶然的病理发现，将按照临床常规进行处理。数据存储在一个安全的在线数据库中。生物样本库样本通过女性的个人识别号码进行识别，并在生物样本库中进行识别后进行化名处理，然后再进行分析。本研究于 2018 年 12 月 28 日获得哥德堡地区伦理审查委员会的批准（批准号 955-18），并于 2019 年 2 月 27 日获得瑞典伦理审查局的批准（批准号 2019-00309）。研究结果将发表在国际同行评议期刊上。
ISRCTN83031502。
