Wojcieszek Aleena M, Shepherd Emily, Middleton Philippa, Gardener Glenn, Ellwood David A, McClure Elizabeth M, Gold Katherine J, Khong Teck Yee, Silver Robert M, Erwich Jan Jaap Hm, Flenady Vicki
NHMRC Centre of Research Excellence in Stillbirth, Mater Research Institute - The University of Queensland (MRI-UQ), Level 3 Aubigny Place, Mater Health Services, Brisbane, Queensland, Australia, 4101.
Cochrane Database Syst Rev. 2018 Apr 30;4(4):CD012504. doi: 10.1002/14651858.CD012504.pub2.
Identification of the causes of stillbirth is critical to the primary prevention of stillbirth and to the provision of optimal care in subsequent pregnancies. A wide variety of investigations are available, but there is currently no consensus on the optimal approach. Given their cost and potential to add further emotional burden to parents, there is a need to systematically assess the effect of these interventions on outcomes for parents, including psychosocial outcomes, economic costs, and on rates of diagnosis of the causes of stillbirth.
To assess the effect of different tests, protocols or guidelines for investigating and identifying the causes of stillbirth on outcomes for parents, including psychosocial outcomes, economic costs, and rates of diagnosis of the causes of stillbirth.
We searched Cochrane Pregnancy and Childbirth's Trials Register (31 August 2017), ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (15 May 2017).
We planned to include randomised controlled trials (RCTs), quasi-RCTs, and cluster-RCTs. We planned to include studies published as abstract only, provided there was sufficient information to allow us to assess study eligibility. We planned to exclude cross-over trials.Participants included parents (including mothers, fathers, and partners) who had experienced a stillbirth of 20 weeks' gestation or greater.This review focused on interventions for investigating and identifying the causes of stillbirth. Such interventions are likely to be diverse, but could include:* review of maternal and family history, and current pregnancy and birth history;* clinical history of present illness;* maternal investigations (such as ultrasound, amniocentesis, antibody screening, etc.);* examination of the stillborn baby (including full autopsy, partial autopsy or noninvasive components, such as magnetic resonance imaging (MRI), computerised tomography (CT) scanning, and radiography);* umbilical cord examination;* placental examination including histopathology (microscopic examination of placental tissue); and* verbal autopsy (interviews with care providers and support people to ascertain causes, without examination of the baby).We planned to include trials assessing any test, protocol or guideline (or combinations of tests/protocols/guidelines) for investigating the causes of stillbirth, compared with the absence of a test, protocol or guideline, or usual care (further details are presented in the Background, see Description of the intervention).We also planned to include trials comparing any test, protocol or guideline (or combinations of tests/protocols/guidelines) for investigating the causes of stillbirth with another, for example, the use of a limited investigation protocol compared with a comprehensive investigation protocol.
Two review authors assessed trial eligibility independently.
We excluded five studies that were not RCTs. There were no eligible trials for inclusion in this review.
AUTHORS' CONCLUSIONS: There is currently a lack of RCT evidence regarding the effectiveness of interventions for investigating and identifying the causes of stillbirth. Seeking to determine the causes of stillbirth is an essential component of quality maternity care, but it remains unclear what impact these interventions have on the psychosocial outcomes of parents and families, the rates of diagnosis of the causes of stillbirth, and the care and management of subsequent pregnancies following stillbirth. Due to the absence of trials, this review is unable to inform clinical practice regarding the investigation of stillbirths, and the specific investigations that would determine the causes.Future RCTs addressing this research question would be beneficial, but the settings in which the trials take place, and their design, need to be given careful consideration. Trials need to be conducted with the utmost care and consideration for the needs, concerns, and values of parents and families. Assessment of longer-term psychosocial variables, economic costs to health services, and effects on subsequent pregnancy care and outcomes should also be considered in any future trials.
确定死产原因对于死产的一级预防以及为后续妊娠提供最佳护理至关重要。有各种各样的调查方法，但目前对于最佳方法尚无共识。鉴于这些调查的成本以及可能给父母增加的情感负担，有必要系统地评估这些干预措施对父母结局的影响，包括心理社会结局、经济成本以及死产原因的诊断率。
评估用于调查和确定死产原因的不同检测、方案或指南对父母结局的影响，包括心理社会结局、经济成本以及死产原因的诊断率。
我们检索了Cochrane妊娠与分娩试验注册库（2017年8月31日）、ClinicalTrials.gov和世界卫生组织国际临床试验注册平台（ICTRP）（2017年5月15日）。
我们计划纳入随机对照试验（RCT）、半随机对照试验和整群随机对照试验。我们计划纳入仅以摘要形式发表的研究，前提是有足够信息使我们能够评估研究的合格性。我们计划排除交叉试验。参与者包括经历过妊娠20周及以上死产的父母（包括母亲、父亲和伴侣）。本综述聚焦于调查和确定死产原因的干预措施。此类干预措施可能多种多样，但可能包括：
回顾母亲和家族史以及当前妊娠和分娩史；
当前疾病的临床病史；
母亲的检查（如超声、羊膜穿刺术、抗体筛查等）；
对死产婴儿的检查（包括完整尸检、部分尸检或非侵入性检查，如磁共振成像（MRI）、计算机断层扫描（CT）和X线摄影）；
脐带检查；
胎盘检查，包括组织病理学检查（胎盘组织的显微镜检查）；
口头尸检（与医护人员和支持人员访谈以确定原因，无需检查婴儿）。
我们计划纳入评估任何用于调查死产原因的检测、方案或指南（或检测/方案/指南的组合）的试验，与未进行检测、方案或指南或常规护理进行比较（背景中提供了更多详细信息，见干预措施描述）。
我们还计划纳入比较任何用于调查死产原因的检测、方案或指南（或检测/方案/指南的组合）与另一种检测、方案或指南的试验，例如，将使用有限调查方案与全面调查方案进行比较。
两位综述作者独立评估试验的合格性。
我们排除了五项非随机对照试验的研究。本综述没有符合纳入标准的试验。
目前缺乏关于调查和确定死产原因的干预措施有效性的随机对照试验证据。寻求确定死产原因是优质产科护理的重要组成部分，但目前尚不清楚这些干预措施对父母和家庭的心理社会结局、死产原因的诊断率以及死产后后续妊娠的护理和管理有何影响。由于缺乏试验，本综述无法为死产调查的临床实践以及确定原因的具体检查提供信息。未来针对这一研究问题的随机对照试验将是有益的，但试验的开展环境及其设计需要仔细考虑。试验的开展需要极其谨慎，并充分考虑父母和家庭的需求、担忧及价值观。任何未来的试验还应考虑对长期心理社会变量的评估、卫生服务的经济成本以及对后续妊娠护理和结局的影响。
