Moderate Hypertension in Pregnancy: Safety and Effectiveness of Treatment

 背景和目的：高血压疾病每年影响美国30万例妊娠，增加了许多不良结局的风险，包括孕产妇和胎儿死亡。妊娠期严重高血压的治疗是常规的。然而，由于对药物治疗的益处的不确定性和对药物可能损害胎儿的担忧，用药物治疗轻度至中度高血压是有争议的。几乎没有严格的证据可以帮助妇女和她们的临床医生权衡治疗的风险和益处。随机试验的规模较小，限制了它们提供结论性答案的能力，特别是在比较不同药物时。到目前为止，观察性研究缺乏实际血压水平的数据，这使得它们无法解释接受不同治疗的女性之间高血压严重程度的差异。没有研究调查治疗的风险和益处是否因母亲的种族/民族或肥胖状况而不同。这项研究将通过使用轻度至中度高血压并发妊娠的真实临床数据来填补这些空白，以确定接受治疗和未接受治疗的妇女以及药物类别和妇女亚组之间的母婴结局差异。结果将提供重要的新证据，以支持更明智和有效的治疗决策。研究方法：本项目是一项回顾性队列研究，在3个综合医疗保健提供系统（Kaiser Permanente北方加州、Kaiser Permanente南方加州和Group Health）内进行，这些系统保存了全面的电子病历（EMR），包括妊娠前和妊娠期间血压值的大量数据。2007年至2014年期间，33，000名患有轻度至中度慢性或妊娠期高血压的孕妇的健康计划数据与州出生和胎儿死亡证明数据相关联，将用于实现这些目标：1）评价药物治疗与不治疗相比对重要的不良母婴结局的影响，同时考虑各组间高血压严重程度和其他因素的差异; 2）比较不同降压药物的临床重要结局风险; 3）确定获益和风险是否因母亲种族/民族或肥胖状态而异。研究的主要结局是先兆子痫、早产、小于胎龄儿、先天性畸形、产妇或新生儿入住重症监护室以及胎儿或婴儿死亡。影响：这项研究将确定治疗轻度至中度妊娠高血压的风险和益处。结果可能会立即影响临床实践，帮助妇女和提供者一起做出更明智的选择。最终，循证治疗将通过帮助临床医生保护孕产妇健康，同时保持胎儿生长和促进足月或近期分娩来改善公共卫生。

 DESCRIPTION (provided by applicant): Background and goals: Hypertensive disorders affect 300,000 pregnancies in the US each year, increasing the risk of many adverse outcomes including maternal and fetal death. Treatment of severe hypertension in pregnancy is routine. Treatment of mild to moderate hypertension with medications is controversial, however, because of uncertainty about the amount of benefit and concern that medications may harm the fetus. Little rigorous evidence exists to help women and their clinicians weigh treatment risks and benefits. Randomized trials have been small in size, limiting their ability to provide conclusive answers, particularly for comparisons of different medications. Observational studies thus far have lacked data on actual blood pressure levels, preventing them from accounting for differences in hypertension severity between women treated in different ways. No studies have investigated whether risks and benefits of treatment differ by maternal race/ethnicity or obesity status. This study will fill these gaps by using real-world clinical data on pregnancies complicated by mild to moderate hypertension to determine how maternal and infant outcomes differ in treated and untreated women as well as between medication classes and subgroups of women. Results will provide important new evidence to support more informed and effective treatment decisions. Methods: This project is a retrospective cohort study set within 3 integrated health care delivery systems (Kaiser Permanente Northern California, Kaiser Permanente Southern California, and Group Health) that maintain comprehensive electronic medical records (EMRs), including extensive data on blood pressure values before and during pregnancy. Health plan data for 33,000 pregnant women with mild to moderate chronic or gestational hypertension delivering from 2007 through 2014, linked to state birth and fetal death certificate data, will be used to address these aims: 1) Evaluate the effect of pharmacologic treatment, compared to no treatment, on important adverse maternal and infant outcomes, while taking into account differences in hypertension severity and other factors between the groups; 2) Compare the risks of clinically important outcomes with different antihypertensive medications; 3) Determine whether the benefits and risks vary by maternal race/ethnicity or obesity status. The primary outcomes to be studied are preeclampsia, preterm birth, small size for gestational age, congenital malformations, maternal or neonatal intensive care unit admission, and fetal or infant death. Impact: This research will determine risks and benefits of treating mild to moderate hypertension in pregnancy. Results may immediately affect clinical practice, helping women and providers make more informed choices together. Ultimately, evidence-based treatment will improve public health by helping clinicians protect maternal health while preserving fetal growth and promoting delivery at or near term.