Chronic Hypertension and Pregnancy-CHAP Clinical Coordinating Center

慢性高血压与妊娠-CHAP临床协调中心

• 批准号: 8696553
• 负责人: ALAN THEVENET N. TITA
• 金额: $ 244.78万
• 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 2020-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8696553
• 关键词: Abruptio Placentae; Acute Kidney Failure; Address; Adherence; American; American College of Obstetricians and Gynecologists; Antihypertensive Agents; Benefits and Risks; Biological; Birth Weight; Blood; Blood flow; Cardiovascular system; Cessation of life; Chronic; Clinical; Clinical Trials Data Monitoring Committees; Clinical Trials Design; Conflict (Psychology); Contingency Fund; Data; Discipline of obstetrics; Disease; Equipoise; Evaluation; Fetal Death; Fetal Growth; Frequencies; Future; General Population; Gestational Age; Goals; Hospitals; Hypertension; Infant; Joints; Kidney; Labetalol; Lead; Measurement; Medical; Methods; Monitor; National Heart, Lung, and Blood Institute; Newborn Infant; Outcome; Participant; Perinatal; Placenta; Policies; Population; Postpartum Period; Pre-Eclampsia; Pregnancy; Pregnancy Outcome; Pregnant Women; Premature Birth; Provider; Public Health; Pulmonary Edema; Randomized; Randomized Clinical Trials; Recommendation; Research; Risk; Safety; Sample Size; Site; Small for Gestational Age Infant; Societies; Specific qualifier value; Stroke; Survival Analysis; Telephone; Umbilical Cord Blood; United States; Withholding Treatment; Woman; adverse outcome; authority; base; blood pressure regulation; clinical research site; cohort; comparative effectiveness; design; experience; fetal; fetal blood; follow-up; hypertension control; neonatal death; offspring; pregnancy hypertension; pressure; public health priorities; public health relevance; randomized trial; trend; working group

PROJECT SUMMARY/ABSTRACT 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 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 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 (longer follow-up is anticipated separately; contingency funds will be considered for interim 6-month phone call). 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 risks of severe maternal cardiovascular outcomes associated with mild CHTN during pregnancy and determine the impact of treatment. ii. To investigate the optimal gestational age to deliver women with CHTN in order to minimize maternal and perinatal complications. We will apply survival analysis methods to the trial population. iii. To collect and store biospecimens including maternal blood, cord blood and placentas for future biological and biophysical studies to understand the effects of antihypertensive therapy in pregnant women with mild CHTN. iv. To assess whether antihypertensive treatment of mild CHTN during pregnancy increases post-pregnancy adherence to recommended therapy.

项目总结/摘要 慢性高血压与妊娠（CHN）项目是一项大型实用的多中心随机临床研究， 一项旨在评价轻度慢性前列腺炎药物治疗的有效性和安全性的试验 妊娠期高血压（CHTN）。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），并与不良结局增加3-5倍相关，包括 先兆子痫、围产期死亡、早产（PTB）和小于胎龄儿（SGA）婴儿（出生体重 <第10百分位）。鉴于抗高血压治疗是普通人群的公共卫生优先事项， 包括美国妇产科医师学会（ACOG）在内的权威机构建议， 妊娠期间降压治疗，除非高血压严重，即，e160/110 mm Hg，因为 不确定的好处和担心治疗实际上可能增加SGA的风险。基于支持 本文提供的初步数据，我们假设妊娠期CHTN的降压治疗， 目前为非妊娠高血压人群推荐的目标<140/90 mmHg， 包括SGA在内的几种不良妊娠结局的风险。在为期6年的项目期间，我们的财团 12个学术围产中心（25个站点），将确定4700名轻度CHTN和BP<155/100 mmHg的妇女 （哪些提供者更舒服不治疗）在怀孕早期，并随机将他们 抗高血压治疗（使用拉贝洛尔）或根据ACOG建议进行管理 （更严重的CHTN的抗高血压治疗）。这些妇女将接受随访，直至出院。 {分娩后和产后3个月内的住院（预计单独进行更长时间的随访;应急基金 将考虑进行为期6个月的临时电话联系）。将实现以下具体目标：} {1.1主要目的：确定妊娠期轻度CHTN的药物治疗是否达到标准化BP 目标<140/90 mmHg，与标准管理相比（根据ACOG：除非高血压，否则不治疗）。 严重），降低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、重度先兆子痫、胎盘脱垂或指示的PTB <35周）和2）SGA。 1.2次要目标： I.为了更好地量化与轻度CHTN相关的重度母体心血管结局的风险， 怀孕和确定治疗的影响。 二.探讨CHTN孕妇分娩的最佳胎龄，以最大限度地减少孕产妇和 围产期并发症我们将对试验人群应用生存分析方法。 三.收集及储存生物样本，包括母血、脐带血及胎盘，以供日后进行生物化验。 和生物物理学研究，以了解抗高血压治疗对轻度高血压孕妇的影响。 CHTN。 四.评估妊娠期间轻度CHTN的降压治疗是否会增加妊娠后 坚持推荐的治疗。