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爱尔兰科克大学D Hayes-Ryan团队研究了胎盘生长因子在评估疑似先兆子痫女性降低孕产妇发病率中的作用。2021年8月13日出版的《英国医学杂志》发表了这项成果。

为了确定将胎盘生长因子（PlGF）检测加入到孕37周前疑似先兆子痫女性的临床评估中，是否可降低产妇发病率且不增加新生儿发病率，2017年6月29日至2019年4月26日，研究组在爱尔兰7家产科医院的全国多站点进行了一项阶梯式楔形群随机对照试验。

研究组招募妊娠20+0至36+6周的单胎妊娠妇女，均有演变为先兆子痫的体征或症状。在接受筛查的5718名女性中，2583名符合条件，最终纳入2313名。将其随机分配，分别接受常规护理，或常规护理联合定点照护PlGF检测。主要结局为综合产妇发病率和新生儿发病率的共同主要结局。使用混合效应泊松回归对个体参与者水平进行分析，并根据治疗意图调整时间效应。

2313名合格参与者中有2219名（96%）被纳入初步分析。其中，1202（54%）名被分配到常规护理组，1017（46%）名被分配到定点照护PlGF检测干预组。常规护理组的产妇发病率为457/1202（38%），定点照护PlGF检测干预组为330/1017（32%），组间差异不显著；常规护理组的新生儿发病率为527/1202（43%），定点照护PlGF检测干预组为484/1017（47%），组间差异亦不显著。

综上，这项在全国多个地点进行的介入诊断试验的实用评估结果不支持将PlGF检测纳入到疑似先兆子痫女性的常规临床调查。

附：英文原文

Title: Placental growth factor in assessment of women with suspected pre-eclampsia to reduce maternal morbidity: a stepped wedge cluster randomised control trial (PARROT Ireland)

Author: D Hayes-Ryan, A S Khashan, K Hemming, C Easter, D Devane, D J Murphy, A Hunter, A Cotter, F M McAuliffe, J J Morrison, F M Breathnach, E Dempsey, L C Kenny, K O’Donoghue

Issue&Volume: 2021/08/13

Abstract:

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.

DOI: 10.1136/bmj.n1857

Source: https://www.bmj.com/content/374/bmj.n1857

BMJ-British Medical Journal:《英国医学杂志》，创刊于1840年。隶属于BMJ出版集团，最新IF：93.333
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