Last updated on March 2019

Chronic Hypertension and Pregnancy (CHAP) Project


Brief description of study

The purpose of this study is to evaluate whether a blood pressure treatment strategy during pregnancy to achieve targets that are recommended for non-pregnant reproductive-age adults (<140/90 mmHg) compared ACOG- recommended standard during pregnancy (no treatment unless BP is severe) is effective and safe.

Detailed Study Description

During pregnancy, chronic hypertension (CHTN) is the most common major medical disorder encountered, occurring in 2-6%. The substantial negative effect of CHTN on pregnancy includes a consistent 3- to 5-fold increase in superimposed preeclampsia and adverse perinatal outcomes (fetal or neonatal death, preterm birth -PTB, poor fetal growth and placental abruption) and possibly a 5- to10-fold increase in maternal cardiovascular and other complications (death, cerebrovascular accident, pulmonary edema and acute renal failure). Mild CHTN (BP <160/110) contributes to a large proportion of these adverse outcomes. While antihypertensive treatment of CHTN is standard for the general population, it is uncertain whether treatment during pregnancy reduces maternal or fetal complications, and there are concerns that decreased arterial pressure may reduce fetal blood flow and cause poor fetal growth or small-for-gestational-age (SGA) infants. Some authorities, including the American College of Obstetricians and Gynecologists (ACOG) and American Society of Hypertension (ASH) recommend withholding antihypertensive therapy for mild CHTN, particularly if BP is <160/105-110 mmHg. The recommendation to withhold antihypertensive treatment in pregnancy conflicts with the broader public health goal to reduce BP in those with CHTN and there is no evidence that discontinuing therapy during the brief period of pregnancy affects maternal outcomes (other than reducing the severe hypertension). For over a decade, authorities have consistently called for well-designed and powered trials to delineate the benefits and risks of pharmacologic therapy for CHTN during pregnancy.

Therefore, our multicenter consortium proposes the Chronic Hypertension and Pregnancy (CHAP) Project, a large pragmatic randomized trial with a primary aim to evaluate the benefits and harms of pharmacologic treatment of mild CHTN in pregnancy.

Clinical Study Identifier: NCT02299414

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General Hospital of San Francisco

San Francisco, CA United States
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Stanford University

Stanford, CA United States
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University of Colorado

Boulder, CO United States
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Denver Health

Denver, CO United States
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Northwestern

Evanston, IL United States
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Indiana University

Bloomington, IN United States
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University of Iowa

Iowa City, IA United States
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Bayview Medical Center

Baltimore, MD United States
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Johns Hopkins University

Baltimore, MD United States
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Beaumont Hospital

Royal Oak, MI United States
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Washington University

Saint Louis, MO United States
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Robert Wood Johnson Medical School

New Brunswick, NJ United States
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St. Peters University Hospital

New Brunswick, NJ United States
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Virtua Medical Group

Sewell, NJ United States
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New York Presbyterian Queens

Flushing, NY United States
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Columbia University

New York, NY United States
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Weill Cornell

New York, NY United States
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University of North Carolina

Chapel Hill, NC United States
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Duke University

Durham, NC United States
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WakeMed

Raleigh, NC United States
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Case Western/Metro Health

Cleveland, OH United States
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Ohio State University

Columbus, OH United States
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Pennsylvania Hospital

Philadelphia, PA United States
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University of Pennsylvania

Philadelphia, PA United States
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Brown (WIHRI)

Providence, RI United States
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UT Southwestern

Dallas, TX United States
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UT Medical Branch

Galveston, TX United States
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Lyndon B. Johnson Hospital

Houston, TX United States
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Baylor College of Medicine

Houston, TX United States
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UT Houston

Houston, TX United States
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McKay Dee Hospital

Ogden, UT United States
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Intermountain Healthcare

Salt Lake City, UT United States
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University of Utah

Salt Lake City, UT United States
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LDS Hospital

Salt Lake City, UT United States
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Gundersen Health System

La Crosse, WI United States
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Marshfield Clinic

Marshfield, WI United States
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Medical College of Wisconsin

Milwaukee, WI United States
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Aurora Research Institute

Milwaukee, WI United States
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Temple University

Philadelphia, PA United States
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New Jersey Medical School

Newark, NJ United States
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Emory University

Atlanta, GA United States
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TriHealth, Inc

Cincinnati, OH United States
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Cleveland Clinic Fairview

Cleveland, OH United States
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Miami Valley Hospital

Dayton, OH United States
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Vanderbilt University

Nashville, TN United States
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Cleveland Clinic-Hillcrest Hospital

Mayfield Heights, OH United States
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Recruitment Status: Open


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