我的宝宝动了：一项提高孕妇孕期对胎儿运动感知的阶梯式楔形集群随机对照试验研究方案。
My Baby's Movements: a stepped wedge cluster randomised controlled trial to raise maternal awareness of fetal movements during pregnancy study protocol.
机构信息
Centre of Research Excellence in Stillbirth, Mater Research Institute, The University of Queensland, Level 3 Aubigny Place Mater Research, South Brisbane QLD, Brisbane, 4101, Australia.
Department of Maternal Fetal Medicine, Mater Misericordiae Limited, Brisbane, Australia.
出版信息
BMC Pregnancy Childbirth. 2019 Nov 21;19(1):430. doi: 10.1186/s12884-019-2575-1.
BACKGROUND
Stillbirth is a devastating pregnancy outcome that has a profound and lasting impact on women and families. Globally, there are over 2.6 million stillbirths annually and progress in reducing these deaths has been slow. Maternal perception of decreased fetal movements (DFM) is strongly associated with stillbirth. However, maternal awareness of DFM and clinical management of women reporting DFM is often suboptimal. The My Baby's Movements trial aims to evaluate an intervention package for maternity services including a mobile phone application for women and clinician education (MBM intervention) in reducing late gestation stillbirth rates.
METHODS/DESIGN: This is a stepped wedge cluster randomised controlled trial with sequential introduction of the MBM intervention to 8 groups of 3-5 hospitals at four-monthly intervals over 3 years. The target population is women with a singleton pregnancy, without lethal fetal abnormality, attending for antenatal care and clinicians providing maternity care at 26 maternity services in Australia and New Zealand. The primary outcome is stillbirth from 28 weeks' gestation. Secondary outcomes address: a) neonatal morbidity and mortality; b) maternal psychosocial outcomes and health-seeking behaviour; c) health services utilisation; d) women's and clinicians' knowledge of fetal movements; and e) cost. 256,700 births (average of 3170 per hospital) will detect a 30% reduction in stillbirth rates from 3/1000 births to 2/1000 births, assuming a significance level of 5%. Analysis will utilise generalised linear mixed models.
DISCUSSION
Maternal perception of DFM is a marker of an at-risk pregnancy and commonly precedes a stillbirth. MBM offers a simple, inexpensive resource to reduce the number of stillborn babies, and families suffering the distressing consequences of such a loss. This large pragmatic trial will provide evidence on benefits and potential harms of raising awareness of DFM using a mobile phone app.
TRIAL REGISTRATION
ACTRN12614000291684. Registered 19 March 2014.
VERSION
Protocol Version 6.1, February 2018.
背景
死胎是一种毁灭性的妊娠结局，对妇女和家庭造成深远而持久的影响。全球每年有超过 260 万例死胎，减少这些死亡的进展一直缓慢。产妇感知胎儿运动减少（DFM）与死胎密切相关。然而，产妇对 DFM 的认识以及对报告 DFM 的妇女的临床管理往往并不理想。My Baby's Movements 试验旨在评估一项产妇服务干预包，包括为妇女提供移动应用程序和临床医生教育（MBM 干预），以降低晚期妊娠死胎率。
方法/设计：这是一项阶梯式楔形集群随机对照试验，在 3 年的时间内，每隔 4 个月向 8 个 3-5 家医院的组序贯引入 MBM 干预。目标人群是在澳大利亚和新西兰的 26 家产科服务机构接受产前护理的单胎妊娠、无致死性胎儿异常的妇女和提供产科护理的临床医生。主要结局是 28 周后死胎。次要结局包括：a）新生儿发病率和死亡率；b）产妇心理社会结局和健康寻求行为；c）卫生服务利用；d）妇女和临床医生对胎儿运动的认识；和 e）成本。预计将有 256700 例分娩（平均每家医院 3170 例），可检测到死胎率从每 1000 例 3 例降至每 1000 例 2 例，假设显著性水平为 5%。分析将利用广义线性混合模型。
讨论
产妇感知 DFM 是一种高危妊娠的标志物，通常先于死胎。MBM 提供了一种简单、廉价的资源，可以减少死产婴儿的数量，并减轻家庭遭受这种损失的痛苦。这项大型实用试验将提供使用移动应用程序提高对 DFM 认识的益处和潜在危害的证据。
试验注册
ACTRN12614000291684。于 2014 年 3 月 19 日注册。
版本
协议版本 6.1，2018 年 2 月。
Zotero 插件