目的:根据CHAP(妊娠期慢性高血压)试验参与者使用的抗高血压药物的类型,评估产妇和新生儿的结局。
方法:我们对CHAP进行了计划的二次分析,一个开放的标签,多中心,在轻度慢性高血压(妊娠20周前血压140-159/90-104mmHg)和单胎妊娠的妊娠患者中,进行抗高血压治疗与标准治疗(除非出现重度高血压,否则不进行治疗)的随机试验.我们根据注册时的处方药物进行了三项比较:拉贝洛尔与标准治疗相比,硝苯地平与标准护理相比,与硝苯地平相比,拉贝洛尔。尽管与标准护理组相比,活动组是随机的,积极治疗组中的药物分配不是随机的,而是基于临床医生或患者的偏好.主要结果是出现了具有严重特征的叠加先兆子痫。妊娠35周前早产,胎盘早剥,或胎儿或新生儿死亡。关键的次要结局是小于胎龄(SGA)的新生儿。我们还比较了两组之间的药物不良反应。用对数二项回归估计相对风险(RR)和95%CI,以校正混淆。
结果:对2,292名参与者进行了分析,720(31.4%)接受拉贝洛尔,417(18.2%)接受硝苯地平,1,155(50.4%)未接受治疗。入组时的平均胎龄为10.5±3.7周;近一半的参与者(47.5%)被确定为非西班牙裔黑人;44.5%使用阿司匹林。主要结局发生在217(30.1%),130(31.2%),拉贝洛尔中的427(37.0%),硝苯地平,和标准护理小组,分别。在接受治疗的患者中,主要结局的风险较低(拉贝洛尔使用与标准调整RR0.82,95%CI,0.72-0.94;硝苯地平使用与标准调整RR0.84,95%CI,0.71-0.99),但是拉贝洛尔与硝苯地平相比,风险没有显着差异(校正RR0.98,95%CI,0.82-1.18)。在接受拉贝洛尔的参与者和接受硝苯地平的参与者之间,SGA或严重不良事件没有显着差异。
结论:在使用拉贝洛尔或硝苯地平治疗妊娠期慢性高血压的基础上,在预定的母体或新生儿结局方面没有发现显著差异。
背景:ClinicalTrials.gov,NCT02299414。
OBJECTIVE: To evaluate maternal and neonatal outcomes by type of antihypertensive used in participants of the CHAP (Chronic Hypertension in Pregnancy) trial.
METHODS: We conducted a planned secondary analysis of CHAP, an open-label, multicenter, randomized trial of antihypertensive treatment compared with standard care (no treatment unless severe hypertension developed) in pregnant patients with mild chronic hypertension (blood pressure 140-159/90-104 mm Hg before 20 weeks of gestation) and singleton pregnancies. We performed three comparisons based on medications prescribed at enrollment:
labetalol compared with standard care, nifedipine compared with standard care, and
labetalol compared with nifedipine. Although active compared with standard care groups were randomized, medication assignment within the active treatment group was not random but based on clinician or patient preference. The primary outcome was the occurrence of superimposed preeclampsia with severe features, preterm birth before 35 weeks of gestation, placental abruption, or fetal or neonatal death. The key secondary outcome was small for gestational age (SGA) neonates. We also compared medication adverse effects between groups. Relative risks (RRs) and 95% CIs were estimated with log binomial regression to adjust for confounding.
RESULTS: Of 2,292 participants analyzed, 720 (31.4%) received
labetalol, 417 (18.2%) received nifedipine, and 1,155 (50.4%) received no treatment. The mean gestational age at enrollment was 10.5±3.7 weeks; nearly half of participants (47.5%) identified as non-Hispanic Black; and 44.5% used aspirin. The primary outcome occurred in 217 (30.1%), 130 (31.2%), and 427 (37.0%) in the
labetalol, nifedipine, and standard care groups, respectively. Risk of the primary outcome was lower among those receiving treatment (
labetalol use vs standard adjusted RR 0.82, 95% CI, 0.72-0.94; nifedipine use vs standard adjusted RR 0.84, 95% CI, 0.71-0.99), but there was no significant difference in risk when labetalol was compared with nifedipine (adjusted RR 0.98, 95% CI, 0.82-1.18). There were no significant differences in SGA or serious adverse events between participants receiving labetalol and those receiving nifedipine.
CONCLUSIONS: No significant differences in predetermined maternal or neonatal outcomes were detected on the basis of the use of labetalol or nifedipine for treatment of chronic hypertension in pregnancy.
BACKGROUND: ClinicalTrials.gov, NCT02299414.