Chronic Hypertension and Pregnancy (CHAP) Project

Summary

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.

Conditions

• Hypertension

Interventions

DRUG

Anti-hypertensive therapy

1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)

OTHER

No anti-hypertensive therapy (unless BP is severe)

Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.

Sponsors & Collaborators

• Columbia University

  collaborator OTHER

• Drexel University College of Medicine

  collaborator OTHER

• Rutgers, The State University of New Jersey

  collaborator OTHER

• Lehigh Valley Hospital

  collaborator OTHER

• Saint Peters University Hospital

  collaborator OTHER

• Christiana Care Health Services

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• Duke University

  collaborator OTHER

• University of Texas Southwestern Medical Center

  collaborator OTHER

• The University of Texas Health Science Center, Houston

  collaborator OTHER

• Stanford University

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• The University of Texas Medical Branch, Galveston

  collaborator OTHER

• University of Utah

  collaborator OTHER

• Intermountain Health Care, Inc.

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• Ochsner Health System

  collaborator OTHER

• University of North Carolina, Chapel Hill

  collaborator OTHER

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• WakeMed Health and Hospitals

  collaborator OTHER

• San Francisco General Hospital

  collaborator OTHER

• McKay-Dee Hospital

  collaborator OTHER

• Winthrop University Hospital

  collaborator OTHER

• New York Hospital Queens

  collaborator OTHER

• Latter Day Saints Hospital

  collaborator OTHER

• Lyndon B Johnson General Hospital

  collaborator OTHER

• Virtua Medical Group

  collaborator OTHER

• Duke Regional Hospital

  collaborator OTHER

• Utah Valley Regional Medical Center

  collaborator OTHER

• Northwestern University

  collaborator OTHER

• Women and Infants Hospital of Rhode Island

  collaborator OTHER

• Baylor College of Medicine

  collaborator OTHER

• Case Western/Metro Health

  collaborator UNKNOWN

• Ohio State University

  collaborator OTHER

• University of Iowa

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• Indiana University

  collaborator OTHER

• Meriter Foundation

  collaborator OTHER

• Weill Medical College of Cornell University

  collaborator OTHER

• University of Oklahoma

  collaborator OTHER

• Medical University of South Carolina

  collaborator OTHER

• Beaumont Hospital

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• University of Kansas Medical Center

  collaborator OTHER

• Denver Health and Hospital Authority

  collaborator OTHER

• Gundersen Health System

  collaborator OTHER

• Wake Forest University Health Sciences

  collaborator OTHER

• Oregon Health and Science University

  collaborator OTHER

• Medical College of Wisconsin

  collaborator OTHER

• Temple University

  collaborator OTHER

• New Jersey Medical School

  collaborator OTHER

• University of South Alabama

  collaborator OTHER

• Vanderbilt University

  collaborator OTHER

• University of Arkansas

  collaborator OTHER

• Emory University

  collaborator OTHER

• St. Luke's Hospital and Health Network, Pennsylvania

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• University of Tennessee

  collaborator OTHER

• TriHealth Inc.

  collaborator OTHER

• Tulane University

  collaborator OTHER

• Yale University

  collaborator OTHER

• Arrowhead Regional Medical Center

  collaborator OTHER

• Geisinger Clinic

  collaborator OTHER

• Miami Valley Hospital

  collaborator OTHER

• University of Alabama at Birmingham

  lead OTHER

Principal Investigators

• Alan Tita, MD, PhD · University of Alabama at Birmingham - Clinical Coordinating Center

• Gary Cutter, PhD · University of Alabama at Birmingham-Data Coordinating Center

• Jeff Szychowski, PhD · University of Alabama at Birmingham-Data Coordinating Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-06-30

Primary Completion

2022-04-01

Completion

2022-12-16

Countries

• United States

Study Locations