Chronic Hypertension and Pregnancy (CHAP): Data Coordinating Center

慢性高血压与妊娠 (CHAP)：数据协调中心

• 批准号: 8914030
• 负责人: GARY R CUTTER
• 金额: $ 39.79万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-01 至 2020-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8914030
• 关键词: Abruptio Placentae; Acute Kidney Failure; Address; Adherence; Alabama; American; American College of Obstetricians and Gynecologists; Antihypertensive Agents; Benefits and Risks; Biological; Biopsy; Birth Weight; Blood; Blood Pressure; Blood flow; Cardiovascular system; Cessation of life; Chronic; Clinical; Clinical Trials Data Monitoring Committees; Clinical Trials Design; Code; Companions; Conflict (Psychology); Data; Data Coordinating Center; Databases; Development Plans; Discipline of obstetrics; Disease; Equipoise; Evaluation; Event; Fetal Death; Fetal Growth; Fetal Growth Retardation; Frequencies; Future; General Population; Genetic Crossing Over; Gestational Age; Goals; Hospitals; Hypertension; Incidence; Institutes; Joints; Kidney; Kidney Failure; Labetalol; Logistics; Maintenance; Manuals; Maternal Age; Medical; Monitor; Myocardial Infarction; National Heart, Lung, and Blood Institute; Obesity; Outcome; Participant; Perinatal; Perinatal mortality demographics; Placebo Control; Placenta; Policies; Population; Postpartum Period; Pre-Eclampsia; Pregnancy; Pregnancy Outcome; Pregnant Women; Premature Birth; Prevalence; Protocols documentation; Provider; Public Health; Pulmonary Edema; Randomized; Randomized Clinical Trials; Recommendation; Reporting; Research; Risk; Safety; Sample Size; Services; Site; Small for Gestational Age Infant; Societies; Specific qualifier value; Stroke; Telephone; Time; Umbilical Cord Blood; United States; Universities; Woman; adverse outcome; arm; authority; base; biophysical analysis; blood pressure reduction; blood pressure regulation; cardiovascular risk factor; clinical application; clinical research site; comparative effectiveness; data management; design; electronic data; experience; fetal blood; follow-up; hypertension control; neonatal death; non-compliance; operation; perinatal outcomes; pregnancy hypertension; pressure; programs; public health priorities; public health relevance; randomized trial; treatment adherence; treatment as usual; treatment effect; trend; working group

DESCRIPTION (provided by applicant): The Chronic Hypertension and Pregnancy (CHAP) project is a large pragmatic multi-center randomized clinical trial designed to evaluate the comparative effectiveness and safety of pharmacologic treatment of mild chronic hypertension (CHTN) in pregnancy. During pregnancy, CHTN is the most common major medical disorder, most often mild (BP <160/110 mmHg), and is associated with a 3-5 fold increase in adverse outcomes including preeclampsia, perinatal death, preterm birth (PTB) and small for gestational age (SGA) infants (birth weight <10th percentile). Whereas antihypertensive therapy is a public health priority for the general population, authorities, including the American College of Obstetricians and Gynecologists (ACOG), recommend against BP lowering therapy during pregnancy unless hypertension is severe, i.e., e160/110 mm Hg, because of uncertain benefits and the concern that therapy may actually increase the risk of SGA. Based on supportive preliminary data presented herein, we hypothesize that antihypertensive therapy for CHTN during pregnancy to the goal <140/90 mmHg as currently recommended for the non-pregnant hypertensive population, will reduce the risk of several adverse pregnancy outcomes including SGA. During a 6-year project period, our consortium of 12 academic perinatal centers (25 sites), will identify 4700 women with mild CHTN and standardized BP<155/100 mmHg (which providers are more comfortable not treating) in early pregnancy and randomize them to either antihypertensive therapy (using labetalol) or to management according to ACOG recommendations (antihypertensive therapy for more severe CHTN). The women will be followed-up until discharge from the hospital after delivery and up to 3 months postpartum (long-term follow-up, including an interim 6-month phone call, is anticipated as a separate related project). The following Specific Aims will be addressed: 1.1 Primary Aim: To determine if pharmacologic treatment of mild CHTN in pregnancy to a standardized BP goal<140/90 mmHg, compared with standard management (per ACOG: no treatment unless hypertension is severe), reduces the risk of adverse pregnancy outcomes including: 1) a severe perinatal composite outcome (perinatal death, severe preeclampsia, placental abruption or indicated PTB <35 weeks) and 2) SGA. 1.2 Secondary Aims: i. To better quantify the incidence during pregnancy of rare maternal cardiovascular risks associated with mild CHTN (including death, myocardial infarction, stroke, renal failure) and examine the effect of treatment. ii. To investigate the optial gestational age to deliver women with CHTN in order to minimize maternal and perinatal complications. iii. To collect and store biospecimens including maternal blood, cord blood and placenta biopsy for future biological and biophysical studies to understand the effects of antihypertensive therapy during pregnancy. iv. To evaluate whether antihypertensive treatment during pregnancy increases post-pregnancy treatment adherence. This application summarizes the trial of the companion application and describes the operations of the DCC to provide full service electronic data capture, reporting and data management services. The extent of these data management services include: database specification, edit check programming, data management plan development and maintenance, ongoing manual data review and query management, medical coding and data cleaning and locking. Specific monitoring of observed blood pressures and blood pressure control along with safety monitoring will be a major endeavor. In addition, the DCC will provide statistical analysis (considering the pragmatic design) and reports which include the data summaries, tables, and statistical analyses for the DSMB.

描述（由申请人提供）：慢性高血压与妊娠（CHAP）项目是一项大型务实的多中心随机临床试验，旨在评估妊娠期轻度慢性高血压（CHTN）药物治疗的相对有效性和安全性。妊娠期间，CHTN 是最常见的主要医学疾病，通常是轻微的（血压 <160/110 mmHg），并且与不良后果增加 3-5 倍相关，包括先兆子痫、围产期死亡、早产 (PTB) 和小产胎龄 (SGA) 婴儿（出生体重<第 10 个百分位数）。尽管抗高血压治疗是一般人群的公共卫生优先事项，但包括美国妇产科医师学会 (ACOG) 在内的当局建议不要在怀孕期间进行降压治疗，除非高血压严重，即 e160/110 mm Hg，因为不确定性以及治疗实际上可能增加 SGA 风险的担忧。基于本文提供的支持性初步数据，我们假设妊娠期 CHTN 抗高血压治疗达到目前建议非妊娠高血压人群<140/90 mmHg 的目标，将降低包括 SGA 在内的多种不良妊娠结局的风险。在为期 6 年的项目期间，我们由 12 个学术围产期中心（25 个地点）组成的联盟将识别 4700 名妊娠早期患有轻度 CHTN 且标准化血压<155/100 mmHg（提供者更愿意不治疗）的女性，并将她们随机分组进行抗高血压治疗（使用拉贝洛尔）或根据 ACOG 建议进行治疗（针对更严重的 CHTN 进行抗高血压治疗）。这些妇女将接受随访，直至产后出院以及产后 3 个月（长期随访，包括为期 6 个月的临时电话，预计将作为一个单独的相关项目）。将解决以下具体目标： 1.1 主要目标：确定与标准治疗（根据 ACOG：除非高血压严重，否则不进行治疗）相比，对妊娠期轻度 CHTN 进行药物治疗至标准化血压目标<140/90 mmHg 是否可以降低血压不良妊娠结局的风险包括：1) 严重的围产期复合结局（围产期死亡、严重先兆子痫、胎盘早剥或指示性 PTB <35 周）和 2) SGA。 1.2 次要目标：为了更好地量化妊娠期间与轻度 CHTN 相关的罕见孕产妇心血管风险（包括死亡、心肌梗死、中风、肾衰竭）的发生率并检查治疗效果。二.调查患有 CHTN 的女性的最佳孕龄，以尽量减少孕产妇和围产期并发症。三.收集和储存包括母血、脐带血和胎盘活检在内的生物样本，用于未来的生物学和生物物理学研究，以了解妊娠期间抗高血压治疗的效果。四.评估妊娠期间的抗高血压治疗是否可以提高妊娠后治疗的依从性。 该应用程序总结了配套应用程序的试用情况，并描述了 DCC 提供全方位电子数据采集、报告和数据管理服务的操作。这些数据管理服务的范围包括：数据库规范、编辑检查编程、数据管理计划开发和维护、持续的手动数据审查和查询管理、医疗编码以及数据清理和锁定。对观察到的血压和血压控制进行具体监测以及安全监测将是一项重大工作。此外，DCC还将提供统计分析（考虑实用设计）和报告，其中包括DSMB的数据摘要、表格和统计分析。