Expectant management of severe preeclampsia remote from term: the MEXPRE Latin Study, a randomized, multicenter clinical trial
Expectant management of severe preeclampsia remote from term: the MEXPRE Latin Study, a randomized, multicenter clinical trial
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DOI：
10.1016/j.ajog.2013.08.016
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发表时间：
2013-11-01
影响因子：
9.8
通讯作者：
Ludmir, Jack
中科院分区：
文献类型：
--
作者：
Vigil-De Gracia, Paulino;Reyes Tejada, Osvaldo;Ludmir, Jack
目的：本研究的目的是确定在资源有限的国家中，在妊娠34周之前对重度先兆子痫进行期待治疗是否会改善新生儿结局。STUDY设计：这是一项在拉丁美洲8家三级医院进行的随机临床试验。随机分组的标准包括妊娠28周至33周之间的胎龄以及是否存在严重的高血压疾病。患者在48小时后被随机分为类固醇类药物加即时分娩组(PD组)和类固醇类药物加期待疗法(EXM组)。结果：共267例患者被随机分为PD组133例和EXM组134例。PD组的妊娠延长时间为2.2天，EXM组为10.3天(P=0.0001)。围产儿死亡率(9.4%vs8.7%；P=.81；相对危险度[RR]，0.91；95%可信区间[CI]，0.34-1.93)和新生儿发病率的组合也没有改善(56.4%vs55.6%；P=.89；RR，01.01；95%CI，0.81-1.26)。与PD组相比，EXM组母体发病率差异无统计学意义(25.2%比20.3%；P=.34；RR，1.24；95%CI，0.79-1.94)。然而，小胎龄(21.7%比9.4%；P=.005；RR，2.27；95%CI，1.21-4.14)和早产在期待治疗中更常见(RR，5.07；95%CI，1.13-22.7；P=.01)。没有孕产妇死亡。结论：这项研究没有证明对28-34周的重度先兆子痫进行期待治疗对新生儿有好处。此外，保守的方法可能会增加早产的风险，而且对胎龄来说很小。
OBJECTIVE: The objective of the study was to determine whether expectant management of severe preeclampsia prior to 34 weeks of gestation results in improved neonatal outcome in countries with limited resources.STUDY DESIGN: This was a randomized clinical trial performed in 8 tertiary hospitals in Latin America. Criteria of randomization included gestational age between 28 and 33 weeks' gestation and the presence of severe hypertensive disorders. Patients were randomized to steroids with prompt delivery (PD group) after 48 hours vs steroids and expectant management (EXM group). The primary outcome was perinatal mortality.RESULTS: A total of 267 patients were randomized, 133 to the PD group and 134 to the EXM group. Pregnancy prolongation was 2.2 days for the PD group vs 10.3 days for the EXM group (P = .0001). The rate of perinatal mortality (9.4% vs 8.7%; P = .81; relative risk [RR], 0.91; 95% confidence interval [CI], 0.34-1.93) was not improved with expectant management, and neither was the composite of neonatal morbidities (56.4% vs 55.6%; P = .89; RR, 01.01; 95% CI, 0.81-1.26). There was no significant difference in maternal morbidity in the EXM group compared with the PD group (25.2% vs 20.3%; P = .34; RR, 1.24; 95% CI, 0.79-1.94). However, small gestational age (21.7% vs 9.4%; P = .005; RR, 2.27; 95% CI, 1.21-4.14) and abruption were more common with expectant management (RR, 5.07; 95% CI, 1.13-22.7; P = .01). There were no maternal deaths.CONCLUSION: This study does not demonstrate neonatal benefit with expectant management of severe preeclampsia from 28 to 34 weeks. Additionally, a conservative approach may increase the risk of abruption and small for gestational age.