创作:尹小甜 审核:Epi汪 2021年08月27日
  • 纳入爱尔兰中2313名20-36周单胎妊娠、有先兆子痫症状的女性,随机分配到常规护理组和额外开展胎盘生长因子(PIGF)检测组;
  • 干预组和对照组的孕妇不良妊娠事件发生率(包括确诊胎盘早剥、重症监护、心功能衰竭等)无统计学差异(32% vs 38%);
  • 而两组的新生儿不良结局发生率(围产期死亡、重症监护、低出生体重、Apgar评分低等)也无统计学差异(47% vs 43%);
  • 目前证据不支持将PlGF检测纳入疑似早产先兆子痫妇女的常规监测。

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



2021-08-13, Article

Abstract & Authors:展开

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 preeclampsia, but nor do they exclude its potential

First Authors:
D Hayes-Ryan

Correspondence Authors:
D Hayes-Ryan

All Authors:
D Hayes-Ryan,AS 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