Fetal movement (FM) is a sign of fetal life and wellbeing that is felt by the pregnant woman, and reduced FM is known to precede stillbirths.^{1, 2} Therefore, healthcare providers may advise women to monitor and report if their babies’ movements are fewer than usual. In high-income countries (HICs), there has been a renewed interest in FM with a recent wave of large-scale randomised controlled clinical trials investigating its potential to reduce stillbirths. The My Baby’s Movement trial in Australia and New Zealand and the Mindfetalness trial in Sweden have investigated the effects of intervention aimed at increasing women’s awareness of FM.^{3, 4} In the UK, the AFFIRM trial investigated the effects of an FM awareness package coupled with a standardised management protocol.⁵ The ongoing CEPRA study in the Netherlands, UK and Australia aims to evaluate Cerebro Placental Ratio as an indicator for delivery in women with reduced FM.⁶ None of the completed trials, however, found significant reductions in stillbirths. Moreover, they showed conflicting results on some potential harmful consequences, such as increased rates of obstetric interventions. In this commentary, we reflect on these trials through a global lens, and we urgently call for more trials – but this time in settings suffering the majority (98%) of the world’s 2 million annual stillbirths.

Importantly, the global applicability of these HIC trials is questionable. They were conducted in settings where women are aware of the importance of reduced FM and are empowered to access the highest standards of care. The contextual realities of pregnancy care are vastly different in low- and middle-income countries (LMICs), where antenatal care and health education are substandard. Women lack health information to self-monitor and report reduced FM. Furthermore, antenatal clinics are often overcrowded and understaffed, and lack supplies, clinical guidelines and the adequate training of health workers. Recent estimates show stillbirth rates of as high as 22 per 1000 total births in sub-Saharan Africa, compared with fewer than 3 per 1000 total births in HICs.⁷ Given the downward trend of stillbirths reported in all the HIC trials, it is possible that the completed trials may be demonstrating a lack of evidence rather than a lack of effectiveness. We hypothesise that involving women in their care, through training on how to monitor their baby’s movement, and when and how to respond, coupled with strengthening healthcare workers’ respect and response to women’s concerns on reduced FM, is a low-cost intervention with potential to significantly reduce stillbirths in high-burden LMICs.

Surprisingly, high-quality studies from LMICs that have assessed the effect of FM interventions on perinatal deaths are lacking.² Of note, the authors of the above-mentioned trials did not consider the well-known major differences in clinical context globally as a limitation while discussing the generalisability of their findings. In fact, the latest My Baby’s Movement trial was not even published with open access, thereby limiting access to less privileged clinicians, researchers and policymakers.⁴ This lack of a global perspective on the international health crisis of preventable stillbirths is an epistemic injustice and a missed opportunity.⁸ We are concerned that the results of the above trials could prematurely prompt policies discouraging the use of FM awareness among pregnant women.⁹ It is thus crucial that the lack of generic applicability of the findings of these trials is stressed, and that their high-resource contexts are considered when developing global clinical guidelines and future research priorities. Notably, it has been seen too often how the unbalanced evidence produced from studies in HICs has had unintended harmful influences on clinical practice in LMICs.¹⁰ For instance, it appears that the breech trials from HICs have also led to policy change in LMICs, with an increased use of caesarean section in the case of breech presentation. However, the risk ratios of vaginal breech births versus caesarean sections differ dramatically between high-resource and low-resource settings, with lower surgical safety in LMICs.^{11, 12}

The prevailing constraints in LMICs should stimulate innovation and creativity to design low-cost solutions that strengthen three areas: (i) FM awareness and monitoring; (ii) diagnosis to identify babies truly at risk; and (3) care provision protocols of pregnant women with reduced FM to improve perinatal outcomes. Although such strategies or their evidence base are often lacking in LMICs, there is some evidence about possible low-cost diagnostic approaches to assess fetal risk following reduced FM: for example, measuring maternal blood pressure, fetal heart rate and fundal height,¹³ or antenatal (handheld) ultrasound to detect and monitor high-risk pregnancies. Measuring fetal blood flow in Doppler ultrasound studies has also been useful, particularly in detecting growth restriction.^{6, 14} Involving women and health workers in studies will ensure the consideration of health-system constraints and allow these to be embedded in the design, implementation and evaluation of any new intervention. If proven effective, this will increase the chance of the seamless integration of the intervention into existing care, and positive perceptions by providers and pregnant women, and will not increase the burden on already overwhelmed healthcare workers.

Unfortunately, maternal perception of FM is still too often the only signal of complications in the absence of regular high-quality antenatal checks,¹⁵ and there are possibly many babies’ lives lost by ignoring this danger sign. Given the burden of need and the context-specific realities that determine the effectiveness of interventions, we hope that these recent waves of FM trials will continue into LMICs to investigate whether and how FM awareness coupled with a context-tailored management protocol can reduce stillbirths.

胎动 (FM) 是孕妇感觉到的胎儿生命和健康的标志，众所周知，胎动减少会先于死产。^{1, 2}因此，医疗保健提供者可能会建议女性监测和报告她们的婴儿胎动是否少于平时。在高收入国家 (HIC)，人们对 FM 重新产生了兴趣，最近一波大规模随机对照临床试验调查了其减少死产的潜力。澳大利亚和新西兰的 My Baby's Movement 试验以及瑞典的 Mindfetalness 试验调查了旨在提高女性对 FM 意识的干预效果。^{3, 4}在英国，AFFIRM 试验调查了 FM 意识包与标准化管理协议相结合的效果。^5个荷兰、英国和澳大利亚正在进行的 CEPRA 研究旨在评估脑胎盘比率作为 FM 减少女性分娩的指标。⁶然而，所有已完成的试验均未发现死产率显着降低。此外，他们在一些潜在的有害后果上显示出相互矛盾的结果，例如产科干预率的增加。在这篇评论中，我们通过全球视角反思这些试验，并紧急呼吁进行更多试验——但这一次是在全世界每年 200 万例死产中的大多数 (98%) 发生的环境中进行。

重要的是，这些 HIC 试验的全球适用性值得怀疑。他们是在女性意识到减少 FM 的重要性并有权获得最高标准护理的环境中进行的。在低收入和中等收入国家 (LMIC)，孕期保健的实际情况大不相同，这些国家的产前保健和健康教育不达标。女性缺乏自我监测和报告 FM 减少的健康信息。此外，产前诊所往往人满为患，人手不足，缺乏用品、临床指南和对卫生工作者的充分培训。最近的估计显示，在撒哈拉以南非洲地区，死产率高达每 1000 名新生儿中有 22 名死产，而在高收入国家中，这一比例不到每 1000 名新生儿中的 3 名。⁷鉴于所有 HIC 试验中报告的死产呈下降趋势，已完成的试验可能表明缺乏证据而不是缺乏有效性。我们假设让女性参与她们的护理，通过培训如何监测婴儿的运动、何时以及如何回应，再加上加强医护人员的尊重和对女性对减少 FM 的担忧的回应，是一种具有潜在潜力的低成本干预措施显着减少高负担中低收入国家的死产。

令人惊讶的是，缺乏来自 LMICs 的高质量研究，这些研究评估了 FM 干预对围产期死亡的影响。²值得注意的是，上述试验的作者在讨论其研究结果的普遍性时，并未将全球临床背景中众所周知的主要差异视为一种限制。事实上，最新的 My Baby's Movement 试验甚至没有公开发表，因此限制了特权较低的临床医生、研究人员和政策制定者的访问。⁴这种对可预防死产的国际健康危机缺乏全球视角是一种认识上的不公正和错失的机会。^8个我们担心上述试验的结果可能会过早地促使政策阻止孕妇使用 FM 意识。⁹因此，必须强调这些试验结果缺乏普遍适用性，并在制定全球临床指南和未来研究重点时考虑它们的高资源背景。值得注意的是，人们经常看到 HIC 研究产生的不平衡证据如何对 LMIC 的临床实践产生意想不到的有害影响。¹⁰例如，HIC 的臀位试验似乎也导致了 LMIC 的政策变化，在臀位的情况下剖腹产的使用增加。然而，阴道臀位分娩与剖腹产的风险比在高资源环境和低资源环境之间存在显着差异，LMIC 的手术安全性较低。^{11, 12}

中低收入国家普遍存在的制约因素应激发创新和创造力，以设计可加强三个领域的低成本解决方案：(i) FM 意识和监测；(ii) 诊断以确定真正处于危险中的婴儿；(3) FM 减少孕妇的护理提供方案，以改善围产期结果。尽管 LMICs 通常缺乏此类策略或其证据基础，但有一些证据表明可能有低成本诊断方法来评估 FM 减少后的胎儿风险：例如，测量产妇血压、胎儿心率和宫底高度 13^或产前（手持式）超声波检测和监测高危妊娠。在多普勒超声研究中测量胎儿血流量也很有用，特别是在检测生长受限方面。^{6, 14}让妇女和卫生工作者参与研究将确保考虑到卫生系统的制约因素，并将这些因素纳入任何新干预措施的设计、实施和评估中。如果证明有效，这将增加将干预措施无缝整合到现有护理中的机会，以及提供者和孕妇的积极看法，并且不会增加已经不堪重负的医护人员的负担。

不幸的是，在缺乏定期高质量产前检查的情况下，母亲对 FM 的感知仍然常常是并发症的唯一信号， ¹⁵并且可能有许多婴儿因忽视这一危险信号而丧生。考虑到决定干预有效性的需求负担和具体情况，我们希望这些最近的 FM 试验浪潮将继续进入 LMIC，以调查 FM 意识与因地制宜的管理协议相结合是否以及如何能够减少死产。