Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial
Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial
复制标题
DOI：
10.1016/s0140-6736(18)31543-5
复制
发表时间：
2018-11-03
期刊：
影响因子：
168.9
通讯作者：
Whyte, Sonia
中科院分区：
文献类型：
--
作者：
Norman, Jane E.;Heazell, Alexander E. P.;Whyte, Sonia
2015年，估计有260万例妊娠以死产告终。AFFIRM研究的目的是验证以下假设，即引入胎动减少（RFM）、孕妇护理方案和临床医生，提高妇女对胎动减少需要及时报告的认识，以及标准化管理，包括及时分娩，将改变死产的发生率。方法在英国和爱尔兰进行了阶梯式、集群随机化试验。使用计算机生成的分配方案，将参与的妇产医院分组并随机分配到九个干预措施实施日期之一（间隔3个月）。直到实施日期前3个月，这个日期才向集群和试验小组隐瞒。每家参与医院有三个观察期：从2014年1月1日至干预开始的随机日期为对照期；自实施之日起2个月的洗脱期；干预期为预选期结束至2016年12月31日。治疗分配没有对参与的妇女和护理人员隐瞒。数据来源于产妇的观察数据。主要结局为死产发生率。根据意向治疗原则进行初步分析，根据分娩是否发生在对照期或干预期进行分析，无论干预是否按计划实施。本研究已在ClinicalTrials注册。网址：NCT01777022。37家医院参与了这项研究。四家医院拒绝参与，33家医院被随机分配到干预实施日期。2014年1月1日至2016年12月31日，共收集409175例妊娠数据（对照组157 692例，洗脱期23 623例，干预期227 860例）。对照组死产发生率为4.40 / 1000例，干预期为4.06 / 1000例（校正优势比[aOR] 0.90, 95% CI 0.75-1.07; p= 0.23）。RFM护理方案并没有降低死产的风险。促进RFM意识的策略的好处尚未得到证实。版权所有(c) 2018作者。Elsevier Ltd.出版。这是一篇基于CC BY 4.0许可的开放获取文章。
Background 2.6 million pregnancies were estimated to have ended in stillbirth in 2015. The aim of the AFFIRM study was to test the hypothesis that introduction of a reduced fetal movement (RFM), care package for pregnant women and clinicians that increased women's awareness of the need for prompt reporting of RFM and that standardised management, including timely delivery, would alter the incidence of stillbirth. Methods This stepped wedge, cluster-randomised trial was done in the UK and Ireland. Participating maternity hospitals were grouped and randomised, using a computer-generated allocation scheme, to one of nine intervention implementation dates (at 3 month intervals). This date was concealed from clusters and the trial team until 3 months before the implementation date. Each participating hospital had three observation periods: a control period from Jan 1, 2014, until randomised date of intervention initiation; a washout period from the implementation date and for 2 months; and the intervention period from the end of the washout period until Dec 31, 2016. Treatment allocation was not concealed from participating women and caregivers. Data were derived from observational maternity data. The primary outcome was incidence of stillbirth. The primary analysis was done according to the intention-to-treat principle, with births analysed according to whether they took place during the control or intervention periods, irrespective of whether the intervention had been implemented as planned. This study is registered with ClinicalTrials. gov, number NCT01777022. Findings 37 hospitals were enrolled in the study. Four hospitals declined participation, and 33 hospitals were randomly assigned to an intervention implementation date. Between Jan 1, 2014, and Dec, 31, 2016, data were collected from 409 175 pregnancies (157 692 deliveries during the control period, 23 623 deliveries in the washout period, and 227 860 deliveries in the intervention period). The incidence of stillbirth was 4.40 per 1000 births during the control period and 4.06 per 1000 births in the intervention period (adjusted odds ratio [ aOR] 0.90, 95% CI 0.75-1.07; p= 0.23). Interpretation The RFM care package did not reduce the risk of stillbirths. The benefits of a policy that promotes awareness of RFM remains unproven. Copyright (c) 2018 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license.