Moderate Hypertension in Pregnancy: Safety and Effectiveness of Treatment

妊娠期中度高血压：治疗的安全性和有效性

• 批准号: 8960648
• 负责人: SASCHA DUBLIN
• 金额: $ 101.26万
• 依托单位: KAISER FOUNDATION HEALTH PLAN OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-05 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8960648
• 关键词: Accounting; Address; Admission activity; Adrenergic beta-Antagonists; Affect; Antihypertensive Agents; Atenolol; Benefits and Risks; Birth; Blood Pressure; Calcium Channel Blockers; California; Characteristics; Chronic; Clinical Data; Cohort Studies; Computerized Medical Record; Congenital Abnormality; Data; Death Certificates; Disease; Effectiveness; Electronics; Ensure; Ethnic Origin; Evidence based treatment; Fetal Death; Fetal Growth; Fetus; Future; Gestational Age; Goals; Health; Health Planning; Hydrochlorothiazide; Hypertension; Infant; Integrated Delivery of Health Care; Knowledge; Labetalol; Lead; Link; Maternal Health; Measurement; Methods; Neonatal Intensive Care Units; Obesity; Observational Study; Outcome; Pharmaceutical Preparations; Pharmacotherapy; Physicians; Population; Population Heterogeneity; Pre-Eclampsia; Pregnancy; Pregnancy Outcome; Pregnant Women; Premature Birth; Provider; Public Health; Race; Randomized Controlled Trials; Research; Resources; Risk; Safety; Severities; Shapes; Subgroup; System; Treatment Effectiveness; Treatment outcome; Uncertainty; Woman; Work; adverse outcome; base; blood pressure regulation; clinical practice; design; effective therapy; improved; individualized medicine; infant death; infant outcome; pregnancy hypertension; prevent; primary outcome; public health relevance; randomized trial; secondary outcome; treatment effect

 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.

 描述（由适用提供）：背景和目标：每年在美国影响300,000次怀孕，增加了许多不良后果的风险，包括母子和胎儿死亡。常规治疗严重的高血压是常规的。但是，用药物治疗轻度至中度高血压是有争议的，因为对药物可能损害胎儿的益处和关注的不确定性。几乎没有严格的证据来帮助妇女及其临床医生的体重治疗风险和收益。随机试验的大小很小，限制了它们提供结论性答案的能力，尤其是对于不同药物的比较。迄今为止，观察性研究缺乏有关实际血压水平的数据，从而阻止了他们以不同方式治疗的女性之间的高血压严重程度的差异。尚无研究调查治疗的风险和益处是否与孕产妇/种族或肥胖状况不同。这项研究将通过使用现实世界中的妊娠临床数据来填补这些空白，从而通过轻度至中度高血压复杂化，以确定孕产妇和婴儿的结局在治疗和未经治疗的妇女以及药物类别和妇女亚组之间的不同之处。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。方法：该项目是一项回顾性队列研究，该研究设置为3个综合医疗保健提供系统（Kaiser Permanente Northerente北加州，Kaiser Permanente南加州和集团健康），其中维持了全面的电子医疗记录（EMRS），包括有关怀孕前后血压值的广泛数据。从2007年到2014年，与州出生和胎儿死亡证书数据相关的33,000名孕妇的健康计划数据将用于解决这些目标：1）评估药物治疗的影响，与未进行治疗相比，对重要的不良产妇和婴儿的重要差异，同时考虑到高度差异，相比之下，将评估药物治疗的效果，以评估药物治疗的影响，以评估药物治疗的效果，同时考虑到高度差异以及其他在相互影响之间的因素之间，将使用与未经治疗的治疗相比，将使用与状态出生和胎儿死亡证书数据有关的数据数据。 2）将临床上重要结果的风险与不同的降压药物进行比较； 3）确定收益和风险是否因孕产妇/种族或肥胖状况而有所不同。要研究的主要结果是先兆子痫，早产，胎龄小小，先天性畸形，母体或新生儿重症监护病房的入院以及胎儿或婴儿死亡。影响：这项研究将确定治疗怀孕中轻度至中度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，基于证据的治疗将通过帮助临床医生保护母子健康，同时保存胎儿生长并在近期促进分娩，从而改善公共卫生。