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）：慢性高血压和妊娠（CHAP）项目是一项庞大的多中心随机临床试验，旨在评估怀孕中轻度慢性高血压（CHTN）的药理学治疗的比较有效性和安全性。在怀孕期间，CHTN是最常见的主要医学疾病，最常见的是轻度（BP <160/110 mmHg），并且与不良后果的3-5倍增加有关，包括前斜率，围产期死亡，早产（PTB）和小男性（SGA）婴儿（SGA）婴儿（出生体重<10th the百分比）。尽管降压治疗是普通人群的公共卫生优先事项，但包括美国产科医生和妇科学院在内的当局（ACOG）建议不要在怀孕期间降低BP降低治疗，除非高血压严重，即E160/110 mm Hg，因为不确定的益处和疗法实际上会增加SGA风险。基于本文提供的支持性初步数据，我们假设怀孕期间CHTN的降压治疗对目标<140/90 mmHg，目前建议用于非妊娠高血压人群，将降低包括SGA在内的几种不良怀孕成果的风险。在6年的项目期间，我们由12个学术周围中心（25个地点）组成的联盟将确定4700名具有轻度CHTN和标准化的BP <155/100 mmHg（提供者在怀孕初期更舒适的妇女），并随机将其随机分配给他们以进行抗高级治疗（使用LabEtalol contagy或Recancetne cog cog thertants antihypertance thantemations（使用抗毒液）。这些妇女将进行随后的跟进，直到分娩后从医院出院和产后3个月（长期随访，包括临时6个月的电话，被预计是一个单独的相关项目）。将解决以下具体目的：1.1主要目的：确定怀孕中轻度CHTN的药理学治疗是否与标准管理相比<140/90 mmHg标准化目标<140/90 mmHg，与标准管理相比（除非高血压，除非高血压是严重的），降低了严重的per症造成损失的风险，包括：1），包括：1）预期症状（1） PTB <35周）和2）SGA。 1.2次要目标：i。为了更好地量化与轻度CHTN相关的罕见母体心血管风险（包括死亡，心肌梗死，中风，肾衰竭）相关的罕见孕妇心血管风险的发生率并检查治疗的影响。 ii。调查胎龄年龄，以递送具有CHTN的女性，以最大程度地减少母体和围产期并发症。 iii。收集和储存生物种子，包括孕妇血液，脐带血和胎盘活检，以进行未来的生物学和生物物理研究，以了解怀孕期间降压治疗的影响。 iv。为了评估怀孕期间的降压治疗是否会增加怀孕后治疗后的依从性。 本应用程序总结了伴侣应用程序的试验，并描述了DCC提供全面服务数据捕获，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，正在进行的手动数据审核和查询管理，医疗编码以及数据清洁和锁定。对观察到的血压和血压控制以及安全监测的特定监测将是一项重大努力。此外，DCC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，表和统计分析。