Fernandes Figueira Institute, Rio de Janeiro, Brazil.
Medical School, Obstetrics Department, Botucatu Sao Paulo State University, Botucatu, Brazil.
BMC Pregnancy Childbirth. 2019 Oct 7;19(1):343. doi: 10.1186/s12884-019-2445-x.
Preeclampsia (PE) is a major cause of short and long-term morbidity for affected infants, including consequences of fetal growth restriction and iatrogenic prematurity. In Brazil, this is a special problem as PE accounts for 18% of preterm births (PTB). In the PREPARE (Prematurity REduction by Pre-eclampsia cARE) study, we will test a novel system of integrated care based on risk stratification and knowledge transfer, to safely reduce PTB.
This is a stepped wedge cluster randomised trial that will include women with suspected or confirmed PE between 20 + 0 and 36 + 6 gestational weeks. All pregnant women presenting with these findings at seven tertiary centres in geographically dispersed sites, throughout Brazil, will be considered eligible and evaluated in terms of risk stratification at admission. At randomly allocated time points, sites will transition to risk stratification performed according to sFlt-1/PlGF (Roche Diagnostics) measurement and fullPIERS score with both results will be revealed to care providers. The healthcare providers of women stratified as low risk for adverse outcomes (sFlt-1/PlGF ≤38 AND fullPIERS< 10% risk) will receive the recommendation to defer delivery. sFlt-1/PlGF will be repeated once and fullPIERS score twice a week. Rates of prematurity due to preeclampsia before and after the intervention will be compared. Additionally, providers will receive an active program of knowledge transfer about WHO recommendations for preeclampsia, including recommendations regarding antenatal corticosteroids for foetal benefits, antihypertensive therapy and magnesium sulphate for seizure prophylaxis. This study will have 90% power to detect a reduction in PTB associated with PE from a population estimate of 1.5 to 1.0%, representing a 33% risk reduction, and 80% power to detect a reduction from 2.0 to 1.5% (25% risk reduction). The necessary number of patients recruited to achieve these results is 750. Adverse events, serious adverse events, both anticipated and unanticipated will be recorded.
The PREPARE intervention expects to reduce PTB and improve care of women with PE without significant adverse side effects. If successful, this novel pathway of care is designed for rapid translation to healthcare throughout Brazil and may be transferrable to other low and middle income countries.
ClinicalTrials.gov : NCT03073317.
子痫前期（PE）是导致受影响婴儿短期和长期发病的主要原因，包括胎儿生长受限和医源性早产的后果。在巴西，这是一个特殊的问题，因为子痫前期占早产（PTB）的 18%。在 PREPARE（子痫前期护理的早产减少）研究中，我们将测试一种基于风险分层和知识转移的新型综合护理系统，以安全地减少早产。
这是一项阶梯式楔形集群随机试验，将包括 20+0 至 36+6 孕周疑似或确诊的子痫前期妇女。在巴西各地七个地理分散的三级中心就诊的所有出现这些发现的孕妇，都将被视为符合条件，并在入院时进行风险分层评估。在随机分配的时间点，根据 sFlt-1/PlGF（罗氏诊断）测量和全 PIERS 评分进行风险分层，向护理提供者透露两者的结果。将低不良结局风险分层的妇女（sFlt-1/PlGF≤38 和全 PIERS<10%风险）的医护人员建议推迟分娩。sFlt-1/PlGF 将每周重复一次，全 PIERS 评分每周两次。干预前后因子痫前期导致的早产率将进行比较。此外，提供者将接受一项关于子痫前期的世卫组织建议的主动知识转移计划，包括关于产前皮质类固醇对胎儿益处、降压治疗和硫酸镁预防癫痫发作的建议。本研究有 90%的把握力，可从人群估计的 1.5%降至 1.0%，降低 33%的风险，有 80%的把握力，可从 2.0%降至 1.5%（降低 25%的风险）。为了达到这些结果，需要招募 750 名患者。将记录不良事件、严重不良事件，包括预期和意外的不良事件。
PREPARE 干预措施预计将降低 PTB 并改善患有 PE 的妇女的护理，而不会产生明显的不良副作用。如果成功，这种新型护理途径旨在快速推广到巴西各地的医疗保健系统，并可能转移到其他低收入和中等收入国家。
ClinicalTrials.gov：NCT03073317。
