Botucatu Medical School, Obstetrics Department, Botucatu Sao Paulo State University, SP, Brazil (L.D.O.).
Magee-Womens Research Institute Department of Obstetrics and Gynecology, Epidemiology and Clinical and Translational Research, Pittsburgh, PA (J.M.R., A.J., K.B.).
Hypertension. 2023 Oct;80(10):2017-2028. doi: 10.1161/HYPERTENSIONAHA.122.20361. Epub 2023 Jul 11.
Early delivery in preterm preeclampsia may reduce the risks for the patient, but consequences of prematurity may be substantial for the baby. This trial evaluated whether the implementation of a risk stratification model could safely reduce prematurity.
This was a stepped-wedge cluster-randomized trial in seven clusters. Patients presenting with suspected or confirmed preeclampsia between 20 and 36 gestational weeks were considered eligible. At the start of the trial, all centers were allocated in the preintervention phase, and patients enrolled in this phase were managed according to local treatment guidance. Subsequently, every 4 months, 1 randomly allocated cluster transitioned to the intervention. Patients enrolled in the intervention phase had sFlt-1 (soluble fms-like tyrosine kinase-1)/PlGF (placental growth factor) ratio and preeclampsia integrated estimate of risk assessments performed. If sFlt-1/PlGF ≤38 and preeclampsia integrated estimate of risk <10%, patients were considered low risk and clinicians received recommendations to defer delivery. If sFlt-1/PlGF >38 and preeclampsia integrated estimate of risk ≥10%, patients were considered not low risk, and clinicians received recommendations to increase surveillance. The primary outcome was the proportion of patients with preterm preeclampsia delivered prematurely out of total deliveries.
Between March 25, 2017 and December 24, 2019, 586 and 563 patients were analyzed in the intervention and usual care groups, respectively. The event rate was 1.09% in the intervention group, and 1.37% in the usual care group. After prespecified adjustments for variation between and within clusters over time, the adjusted risk ratio was 1.45 ([95% CI, 1.04-2.02]; =0.029), indicating a higher risk of preterm deliveries in the intervention group. Post hoc analysis including calculation of risk differences did not show evidence of statistical differences. Abnormal sFlt-1/PlGF was associated with a higher rate of identifying preeclampsia with severe features.
The introduction of an intervention based on biomarkers and clinical factors for risk stratification did not lead to reductions in preterm deliveries. Further training on the interpretation of disease severity in preeclampsia and the development of additional risk stratification is needed before adoption into clinical practice.
URL: https://www.
gov; Unique identifier: NCT03073317.
在早产先兆子痫中提前分娩可能会降低患者的风险，但早产对婴儿的影响可能很大。本试验评估了实施风险分层模型是否可以安全地减少早产。
这是一项在七个群组中进行的分步楔形集群随机试验。在妊娠 20 至 36 周之间出现疑似或确诊先兆子痫的患者被认为符合条件。在试验开始时，所有中心都被分配在干预前阶段，在此阶段招募的患者根据当地治疗指南进行管理。随后，每 4 个月，1 个随机分配的群组过渡到干预阶段。招募的干预阶段的患者进行 sFlt-1（可溶性 fms 样酪氨酸激酶-1）/PlGF（胎盘生长因子）比值和子痫前期综合风险评估。如果 sFlt-1/PlGF≤38 且子痫前期综合风险<10%，则患者被认为是低风险，临床医生会收到延迟分娩的建议。如果 sFlt-1/PlGF>38 且子痫前期综合风险≥10%，则患者被认为是高风险，临床医生会收到增加监测的建议。主要结局是早产儿早产的早产儿比例占总分娩数的比例。
2017 年 3 月 25 日至 2019 年 12 月 24 日，干预组和常规护理组分别分析了 586 名和 563 名患者。干预组的事件发生率为 1.09%，常规护理组为 1.37%。经过预先规定的调整，以反映时间内组间和组内的变化，调整后的风险比为 1.45（[95%CI，1.04-2.02]；=0.029），表明干预组早产儿分娩的风险更高。包括计算风险差异的事后分析并未显示出统计学差异的证据。异常的 sFlt-1/PlGF 与识别具有严重特征的子痫前期的发生率更高相关。
引入基于生物标志物和临床因素的风险分层干预措施并未导致早产率降低。在将其纳入临床实践之前，需要进一步培训子痫前期疾病严重程度的解释和开发其他风险分层方法。
网址：https://www.
gov；唯一标识符：NCT03073317。
