Departments of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, and University of South Alabama at Mobile, Mobile, Alabama, University of North Carolina at Chapel Hill, Chapel Hill, and Duke University, Durham, North Carolina, University of Pennsylvania and Drexel University College of Medicine, Philadelphia, and Magee Women's Hospital and University of Pittsburgh, Pittsburgh, Pennsylvania, University of Texas at Houston and the Division of Maternal-Fetal Medicine, Baylor College of Medicine and Texas Children's Hospital, Houston, and University of Texas Medical Branch, Galveston, Texas, Columbia University and Weill Cornell University, New York, and New York Presbyterian Queens Hospital, Flushing, New York, University of Oklahoma Health Sciences, Oklahoma City, Oklahoma, Indiana University, Indianapolis, Indiana, University of Utah and Intermountain Healthcare, Salt Lake City, Utah, UnityPoint Health-Meriter Hospital/Marshfield Clinic, Madison, Wisconsin, Washington University in St. Louis, St. Louis, Missouri, University of Mississippi Medical Center, Jackson, Mississippi, The Ohio State University, Columbus, Ohio, Rutgers University-Robert Wood Johnson Medical School, New Brunswick, New Jersey, Medical College of Wisconsin, Milwaukee, Wisconsin, Yale University, New Haven, Connecticut, University of Colorado, Aurora, and Denver Health, Denver, Colorado, Emory University, Atlanta, Georgia.
University of California San Francisco, San Francisco, and Stanford University, Stanford, California, and Arrowhead Regional Medical Center/Beaumont Hospital, Michigan, Detroit, Michigan; the Center for Women's Reproductive Health, the Department of Biostatistics and the Division of Neonatology, Department of Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama; St. Luke's University Health Network, Bethlehem, Pennsylvania; MetroHealth System, Cleveland, Ohio; Ochsner Baptist Medical Center, New Orleans, Louisiana; Christiana Care Health Services, Newark, Delaware; St. Peters University Hospital, New Brunswick, New Jersey; Zuckerberg San Francisco General Hospital, San Francisco, California; the Division of Cardiovascular Sciences and the Office of Biostatistics Research, National Heart, Lung, and Blood Institute, Bethesda, Maryland; and the Department of Women's Health, University of Texas at Austin, Austin, Texas.
Obstet Gynecol. 2024 Jul 1;144(1):126-134. doi: 10.1097/AOG.0000000000005613. Epub 2024 May 23.
To evaluate maternal and neonatal outcomes by type of antihypertensive used in participants of the CHAP (Chronic Hypertension in Pregnancy) trial.
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.
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.
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.
ClinicalTrials.gov, NCT02299414.
评估 CHAP（妊娠慢性高血压）试验中使用的降压药物对母婴结局的影响。
我们对 CHAP 进行了计划中的二次分析，这是一项开放标签、多中心、随机试验，比较了抗高血压治疗与标准护理（除非发生严重高血压，否则不治疗）在患有轻度慢性高血压（妊娠 20 周前血压为 140-159/90-104mmHg）和单胎妊娠的孕妇中的效果。我们根据入组时开具的药物进行了三项比较：拉贝洛尔与标准护理相比、硝苯地平与标准护理相比以及拉贝洛尔与硝苯地平相比。尽管与标准护理组相比，活性药物组是随机分组的，但药物的分配在活性治疗组内并非随机，而是基于临床医生或患者的偏好。主要结局是出现严重特征的重叠子痫前期、35 周前早产、胎盘早剥或胎儿或新生儿死亡。关键次要结局是胎儿生长受限（SGA）新生儿。我们还比较了各组之间的药物不良反应。使用对数二项式回归估计相对风险（RR）和 95%CI，以调整混杂因素。
在分析的 2292 名参与者中，720 名（31.4%）接受了拉贝洛尔治疗，417 名（18.2%）接受了硝苯地平治疗，1155 名（50.4%）未接受治疗。入组时的平均妊娠年龄为 10.5±3.7 周；近一半的参与者（47.5%）是非西班牙裔黑人；44.5%使用了阿司匹林。拉贝洛尔、硝苯地平和标准护理组的主要结局发生率分别为 217（30.1%）、130（31.2%）和 427（37.0%）。接受治疗的患者发生主要结局的风险较低（拉贝洛尔治疗 vs 标准治疗调整 RR 0.82，95%CI，0.72-0.94；硝苯地平治疗 vs 标准治疗调整 RR 0.84，95%CI，0.71-0.99），但拉贝洛尔与硝苯地平相比，风险无显著差异（调整 RR 0.98，95%CI，0.82-1.18）。接受拉贝洛尔和硝苯地平治疗的患者在 SGA 或严重不良事件方面无显著差异。
基于治疗妊娠慢性高血压使用拉贝洛尔或硝苯地平，未发现预定的母婴结局有显著差异。
ClinicalTrials.gov，NCT02299414。
