Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
4700

Summary

Conditions
Hypertension
Type
Interventional
Phase
Phase 4
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 12 years and 125 years
Gender
Only males

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 deat...

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.

Tracking Information

NCT #
NCT02299414
Collaborators
  • Drexel University College of Medicine
  • Columbia University
  • University of Iowa
  • Unity Point Health-Meriter Hospital WI
  • Emory University
  • Aurora Health Care
  • Rutgers, The State University of New Jersey
  • Lehigh Valley Hospital
  • Saint Peters University Hospital
  • Cleveland Clinic Fairview Hospital
  • University of Oklahoma
  • St. Luke's Hospital and Health Network, Pennsylvania
  • Christiana Care Health Services
  • McKay-Dee Hospital
  • University of Arkansas
  • Utah Valley Regional Medical Center
  • San Francisco General Hospital
  • Washington University School of Medicine
  • University of Pittsburgh
  • Arrowhead Regional Medical Center
  • Duke University
  • University of Texas Southwestern Medical Center
  • Latter Day Saints Hospital
  • Tulane University
  • Lyndon B Johnson General Hospital
  • University of Colorado, Denver
  • Cleveland Clinic Hillcrest Hospital
  • University of California, San Diego
  • Yale University
  • Beaumont Hospital
  • Northwestern
  • Case Western/Metro Health
  • Virtua Medical Group
  • New York Hospital Queens
  • Indiana University
  • Medical University of South Carolina
  • Ohio State University
  • Denver Health and Hospital Authority
  • Oregon Health and Science University
  • National Heart, Lung, and Blood Institute (NHLBI)
  • New Jersey Medical School
  • Baylor College of Medicine
  • Temple University
  • Winthrop University Hospital
  • University of California, San Francisco
  • The University of Texas Health Science Center, Houston
  • Duke Regional Hospital
  • University of Kansas Medical Center
  • University of Tennessee Health Science Center
  • Bayview Medical Center
  • TriHealth Inc.
  • Weill Medical College of Cornell University
  • Johns Hopkins University
  • Miami Valley Hospital
  • Gundersen Health System
  • University of South Alabama
  • University of North Carolina, Chapel Hill
  • University of Utah
  • Intermountain Health Care, Inc.
  • WakeMed Health and Hospitals
  • Vanderbilt University
  • Stanford University
  • University of Pennsylvania
  • Geisinger Clinic
  • Brown (WIHRI)
  • The University of Texas Medical Branch, Galveston
  • Medical College of Wisconsin
  • Ochsner Health System
Investigators
Principal Investigator: Alan Tita, MD, PhD University of Alabama at Birmingham - Clinical Coordinating Center Principal Investigator: Gary Cutter, PhD University of Alabama at Birmingham-Data Coordinating Center