Objective To determine whether the addition of placental growth factor (PlGF) measurement to current clinical assessment of women with suspected pre-eclampsia before 37 weeks' gestation would reduce maternal morbidity without increasing neonatal morbidity. Design Stepped wedge cluster randomised control trial from 29 June 2017 to 26 April 2019. Setting National multisite trial in seven maternity hospitals throughout the island of Ireland Participants Women with a singleton pregnancy between 20+0 to 36+6 weeks’ gestation, with signs or symptoms suggestive of evolving pre-eclampsia. Of the 5718 women screened, 2583 were eligible and 2313 elected to participate. Intervention Participants were assigned randomly to either usual care or to usual care plus the addition of point-of-care PlGF testing based on the randomisation status of their maternity hospital at the time point of enrolment. Main outcomes measures Co-primary outcomes of composite maternal morbidity and composite neonatal morbidity. Analysis was on an individual participant level using mixed-effects Poisson regression adjusted for time effects (with robust standard errors) by intention-to-treat. Results Of the 4000 anticipated recruitment target, 2313 eligible participants (57%) were enrolled, of whom 2219 (96%) were included in the primary analysis. Of these, 1202 (54%) participants were assigned to the usual care group, and 1017 (46%) were assigned the intervention of additional point-of-care PlGF testing. The results demonstrate that the integration of point-of-care PlGF testing resulted in no evidence of a difference in maternal morbidity—457/1202 (38%) of women in the control group versus 330/1017 (32%) of women in the intervention group (adjusted risk ratio (RR) 1.01 (95% CI 0.76 to 1.36), P=0.92)—or in neonatal morbidity—527/1202 (43%) of neonates in the control group versus 484/1017 (47%) in the intervention group (adjusted RR 1.03 (0.89 to 1.21), P=0.67). Conclusions This was a pragmatic evaluation of an interventional diagnostic test, conducted nationally across multiple sites. These results do not support the incorporation of PlGF testing into routine clinical investigations for women presenting with suspected preterm pre-eclampsia, but nor do they exclude its potential benefit. Trial registration ClinicalTrials.gov [NCT02881073][1]. Relevant anonymised patient level data available on reasonable request from the corresponding author. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02881073&atom=%2Fbmj%2F374%2Fbmj.n1857.atom

中文翻译：

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胎盘生长因子在评估疑似先兆子痫妇女以降低产妇发病率：阶梯楔形集群随机对照试验（PARROT Ireland）

目的 确定在目前对妊娠 37 周前疑似先兆子痫妇女的临床评估中增加胎盘生长因子 (PlGF) 测量是否会降低产妇发病率而不增加新生儿发病率。设计 2017 年 6 月 29 日至 2019 年 4 月 26 日的阶梯楔形集群随机对照试验。在整个爱尔兰岛的七家妇产医院设置国家多中心试验参与者在 20+0 至 36+6 孕周之间单胎妊娠的女性，有体征或提示发生先兆子痫的症状。Of the 5718 women screened, 2583 were eligible and 2313 elected to participate. 干预 参与者被随机分配到常规护理组或常规护理组，并根据入组时产科医院的随机化状态添加床旁 PlGF 测试。主要结果衡量复合产妇发病率和复合新生儿发病率的共同主要结果。分析是在个体参与者水平上使用混合效应泊松回归通过意向治疗调整了时间效应（具有稳健的标准误差）。结果 在 4000 名预期招募目标中，2313 名符合条件的参与者（57%）被纳入，其中 2219 名（96%）被纳入初步分析。其中，1202 名 (54%) 参与者被分配到常规护理组，1017 名 (46%) 被分配到额外的即时 PlGF 测试干预。结果表明，床旁 PlGF 检测的整合并未导致孕产妇发病率存在差异——对照组女性为 457/1202 (38%)，而对照组女性为 330/1017 (32%)干预组（调整后的风险比 (RR) 1.01（95% CI 0.76 至 1.36），P=0.92）—或在新生儿发病率中—对照组新生儿的 527/1202 (43%) 与 484/1017 (47%)在干预组中（调整后的 RR 1.03（0.89 至 1.21），P=0.67）。结论 这是对介入诊断测试的务实评估，在全国多个地点进行。这些结果不支持将 PlGF 检测纳入疑似早产先兆子痫妇女的常规临床调查，但也不排除其潜在益处。试验注册 ClinicalTrials.gov [NCT02881073][1]。可根据通讯作者的合理要求提供相关的匿名患者水平数据。[1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02881073&atom=%2Fbmj%2F374%2Fbmj.n1857.atom