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Chronic Hypertension and Pregnancy-CHAP Clinical Coordinating Center

慢性高血压与妊娠-CHAP临床协调中心

基本信息

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
项目类别：
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

项目摘要

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.

项目概要/摘要慢性高血压与妊娠（CHAP）项目是一项大型务实的多中心随机临床研究旨在评估轻度慢性药物治疗的比较有效性和安全性的试验妊娠期高血压（CHTN）。怀孕期间，CHTN 是最常见的主要疾病，最常见的是轻度（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) 和小于胎龄 (SGA) 婴儿（出生体重） <第 10 个百分位数）。鉴于抗高血压治疗是普通人群的公共卫生优先事项，包括美国妇产科学院 (ACOG) 在内的权威机构建议不要怀孕期间进行降压治疗，除非高血压严重，即 e160/110 mm Hg，因为不确定的益处以及治疗实际上可能增加 SGA 风险的担忧。基于支持本文提供的初步数据，我们假设妊娠期间 CHTN 的抗高血压治疗目前建议非妊娠高血压人群的目标<140/90 mmHg，将减少包括 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，我们的联合体 12 个学术围产期中心（25 个地点）将鉴定 4700 名患有轻度 CHTN 且血压<155/100 mmHg 的女性（哪些提供者更愿意不治疗）在怀孕早期并将其随机分配到抗高血压治疗（使用拉贝洛尔）或根据 ACOG 建议进行管理（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出院 {产后和产后 3 个月内住院（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 个月的临时电话通话）。将解决以下具体目标：} {1.1 主要目标：确定妊娠期轻度 CHTN 的药物治疗是否可达到标准化血压} 与标准管理相比，目标<140/90 mmHg（根据ACOG：除非高血压，否则不进行治疗严重），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、严重先兆子痫、胎盘早剥或指征 PTB <35 周）和 2) SGA。 1.2 次要目标：我。为了更好地量化与轻度 CHTN 相关的严重孕产妇心血管结局的风险妊娠并确定治疗的影响。二.调查患有 CHTN 的妇女分娩的最佳孕龄，以尽量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.收集和储存包括母血、脐带血和胎盘在内的生物样本，以供将来的生物样本使用和生物物理学研究，以了解抗高血压治疗对轻度妊娠妇女的影响 CHTN。四.评估妊娠期间轻度 CHTN 的抗高血压治疗是否会增加妊娠后的风险坚持推荐的治疗。