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：
8914032
负责人：
ALAN THEVENET N. TITA
金额：
$ 280.46万
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 2020-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8914032
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 Health Hospitals Hypertension Infant Joints Kidney Labetalol Lead Measurement Medical Methods Monitor National Heart, Lung, and Blood Institute Newborn Infant Outcome Participant Perinatal Perinatal mortality demographics 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 biophysical analysis blood pressure reduction blood pressure regulation clinical research site cohort comparative effectiveness design experience fetal fetal blood follow-up hypertension control neonatal death offspring perinatal outcomes pregnancy hypertension pressure public health priorities randomized trial trend trial design working group

项目摘要

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 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.

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障碍，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）的婴儿（出生体重<10th histeraile）。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。在一个为期6年的项目期间，我们组成的12个学术围产期中心（25个地点）将确定4700名轻度CHTN和BP <155/100 mmHg（提供者更舒适地不治疗）在怀孕初期，并随机将其随机进行随机治疗，以根据Antypertansive（使用Labetalol）或对抗抑制作用的治疗（使用Labetalol）或Antipertens（使用抗抑制作用）（使用Antypertens）。这些妇女将进行跟进，直到从分娩后的医院和产后最多3个月的医院出院（预计会单独进行更长的随访；应急资金将用于临时6个月的电话）。 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突发或指示的PTB <35周）和2）SGA。 1.2次要目标：i。更好地量化与怀孕期间与轻度CHTN相关的严重母体心血管结局的风险，并确定治疗的影响。 ii。为了调查提供CHTN女性的最佳胎龄，以最大程度地减少母体和围产期并发症。我们将对试验人群应用生存分析方法。 iii。收集和储存生物种子，包括孕产妇血液，脐带血和胎盘，以进行未来的生物学和生物物理研究，以了解降压治疗对轻度CHTN孕妇的影响。 iv。为了评估怀孕期间轻度CHTN的降压治疗是否会增加怀孕后依从性推荐治疗。